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Welcome to 510kDecisions.com. This website contains over 132,000 FDA 510(k) applications and decisions collected since May, 1976 from the U.S. Food and Drug Administration's publicly available databases of FDA Device Approvals and Clearances. Additionally, we have provided convenient cross-linking of records by applicant company name, contact name, device classification, and product code. Things You Can Do With This Website:. Check the status of an FDA 510(k) Application by browsing to it by company name.
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Welcome to one of Florida's leading Investigational new Drug and medical device research centers. Since 1987, the staff at Therafirst Medical Centers have dedicated themselves to testing the most promising, newly available treatment medications being presented for FDA approval. Patient confidentially is maintained while still being able to obtain medications vital to a person's health. Studies and protocols for new medications and devices. Medical Device studies for 510(k) clearance.
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Welcome to one of Florida's leading Investigational new Drug and medical device research centers. Since 1987, the staff at Therafirst Medical Centers have dedicated themselves to testing the most promising, newly available treatment medications being presented for FDA approval. Patient confidentially is maintained while still being able to obtain medications vital to a person's health. Studies and protocols for new medications and devices. Medical Device studies for 510(k) clearance.
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510K Medical Device Premarket notification submissions. Get an ACCURATE and QUICK quote and GAP ANALYSIS for your medical device FDA clearance. Our website links to FDA databases - which will be reflected within the screens as you fill out certain information. You’ll receive our regulatory report shortly after you complete the data entry. 2017 - 2018 Privacy Policy. Our website is backed up daily and is guaranteed an up time of 99.999%.
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Medical and Dental Device Approvals. FDA 510(k) Medical Device Clearance. Call - 1 386-453-1214. All medical devices are regulated by the U.S. Food And Drug Administration (FDA). The Agency allows three broad pathways to obtain approval . The 510(k) Premarket Notification program is a relatively inexpensive pathway for companies to obtain regulatory clearance to introduce me, too medical products . Posted by Steve Chard. On Jun 2, 2014. Posted by Steve Chard. On Jun 2, 2014. Posted by Steve Chard. FDA 51...
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