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NU-DEVICE.COM

Nu Device Consulting LLC

Offers regulatory services pertaining to medical devices. Our customers are manufacturers and importers.

http://www.nu-device.com/

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Jean Bigoney

127 ●●●●n St

PO ●●●826

Spri●●●●ield , Vermont, 05156-0826

United States

(802)●●●●●-8026
(802)●●●●●-8086
sm●●●●@vermontel.net

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SMS, Inc.

Jean Bigoney

127 ●●●●n St

PO ●●●826

Spri●●●●ield , Vermont, 05156-0826

United States

(802)●●●●●-8026
(802)●●●●●-8086
sm●●●●@vermontel.net

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Nu Device Consulting LLC | nu-device.com Reviews
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Offers regulatory services pertaining to medical devices. Our customers are manufacturers and importers.
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3 510(k)
4 medical device
5 medical devices
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Nu Device Consulting LLC | nu-device.com Reviews

https://nu-device.com

Offers regulatory services pertaining to medical devices. Our customers are manufacturers and importers.

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nu-device.com nu-device.com
1

FDA Regulatory Services offered by Nu Device Consulting LLC

http://www.nu-device.com/FDAreg.htm

HCPCS Level II Coding. The most common request is for assistance with a 510(k) application. Depending on the development stage of the product, materials may or may not be available to put together a successful application. That is why the first step is to perform a gap analysis to determine what what the customer still needs to do before submitting the application. Please check the "FDA 510(k) Submissions" page to see what is involved. As far as the FDA is concerned, "The responsibilities of the U.S&...

2

News and Updates from Nu Device Consulting LLC

http://www.nu-device.com/whatsnew.htm

HCPCS Level II Coding. Recent Developments Relating to 513(g) Requests for Classification. January / February 2009:. Imported Products-FDA Is Not Fooling Around. September 30, 2009:. Firms Warn of Delays from FDA Scrutiny. December 30, 2009:. Is the FDA Too Easy On Medical Devices? January 11, 2010:. State Marketing Laws Impacting Medical Device Manufacturers. Plan of Action for Implementation of 510(k) and Science Recommendations. February 14, 2011:. Device Recalls Blamed on Lax FDA Approval Path. FDA p...

3

12 Steps to 510(k) Market Clearance from Nu Device Consulting LLC

http://www.nu-device.com/FDA510k.htm

HCPCS Level II Coding. Getting 510(k) clearance is straightforward, but attention to detail is crucial. As a minimum, here are twelve steps that have to be completed. If you are considering submitting a 510(k) for your device, this list can help you decide whether existing documents and information are sufficient to prepare a successful application. 12 Steps to obtaining Market Clearance for your Medical Device. Find the three-letter Product Code. One way is to search the online FDA 510(k) database.

4

Helpful Links - Nu Device Consulting LLC

http://www.nu-device.com/links.htm

HCPCS Level II Coding. Here are some helpful links with time-saving online resources. FDA Registration and Fees. Registration and Listing Information. Sec 807.90 (Code of Federal Regulations Title 21). Electronic Registration and Listing System (FURLS). Establishment Registration and Medical Device Listing Files for Download. Who must register and pay. Medical Device User Fee Rates. Medical Device User Fee Cover Sheet (Example). FDA Database Search Pages. CDRH Database Super Search. HCPCS Level II Codes.

5

Nu Device Consulting LLC

http://www.nu-device.com/index.htm

HCPCS Level II Coding. Your medical device deserves a regulatory strategy of its own. FDA 510(k) submissions (Class I and Class II). Reimbursement strategy, including HCPCS Level II Coding verification and modification requests. FDA Registration and Listing. US State Medical Device manufacturer registration. 210 Farmers Top, Murphy NC 28906. Tel: (603) 477-7685 Fax: (603) 869-7669.

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Partner and Service Provider. The website operator takes over no liability for the contents of external Internet pages which are accessible about links from this web page or which refer for their part to this web page. If you want us to link your website to this page. URL: www.wetteronline.de/Bayern.htm. URL: www.accellab.com. Antimicrobial / (anti-)adhesive materials testing. URL: www.bmpaachen.de. URL: www.mdservices.de. BSL BIOSERVICE Scientific Laboratories. URL: www.bioservice.com.

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Partner and Service Provider. The website operator takes over no liability for the contents of external Internet pages which are accessible about links from this web page or which refer for their part to this web page. If you want us to link your website to this page. URL: www.wetteronline.de/Bayern.htm. URL: www.accellab.com. Antimicrobial / (anti-)adhesive materials testing. URL: www.bmpaachen.de. URL: www.mdservices.de. BSL BIOSERVICE Scientific Laboratories. URL: www.bioservice.com.

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Partner and Service Provider. The website operator takes over no liability for the contents of external Internet pages which are accessible about links from this web page or which refer for their part to this web page. If you want us to link your website to this page. URL: www.wetteronline.de/Bayern.htm. URL: www.accellab.com. Antimicrobial / (anti-)adhesive materials testing. URL: www.bmpaachen.de. URL: www.mdservices.de. BSL BIOSERVICE Scientific Laboratories. URL: www.bioservice.com.

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Partner and Service Provider. The website operator takes over no liability for the contents of external Internet pages which are accessible about links from this web page or which refer for their part to this web page. If you want us to link your website to this page. URL: www.wetteronline.de/Bayern.htm. URL: www.accellab.com. Antimicrobial / (anti-)adhesive materials testing. URL: www.bmpaachen.de. URL: www.mdservices.de. BSL BIOSERVICE Scientific Laboratories. URL: www.bioservice.com.

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HCPCS Level II Coding. Your medical device deserves a regulatory strategy of its own. FDA 510(k) submissions (Class I and Class II). Reimbursement strategy, including HCPCS Level II Coding verification and modification requests. FDA Registration and Listing. US State Medical Device manufacturer registration. 210 Farmers Top, Murphy NC 28906. Tel: (603) 477-7685 Fax: (603) 869-7669.

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