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510(k) information web site for FDA 510(k) information
Transfer of a Premarket Notification. Medical Device User Fees 2015. Changes to Quality System Regulations. Expansion of 510(k) Pilot. FDA Intends to Require PMAs for Some Defibrillator. Notice to Denture Adhesive Manufacturers. FDA Publishes Revised Process-Validation Guidance. FDA’s 515 Initiative program. FDA launches Medical Device Innovation Initiative. Process for devices, agents is ‘broken’. 510(k) and 513(g) submissions - update. Medical Device User Fee Rates for 2011. Expansion of 510(k) Pilot.
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FDA 510(k) Applications Database
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 510K technology Group
Therafirst Medical Centers | Investigational New Drug and Medical Device Research Center
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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