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Accession Number AVA16114-VNB1
Title Medical Device Regulations: Premarket Notification - The 510(k) Process.
Publication Date 1994
Media Count 1AV-VHS 1/2 inch - 1 cassette
Personal Author N/A
Abstract This program describes the premarket notification, known as the 510(k) process. 510(k) is the mechanism through which new medical devices are screened by the FDA before they may be placed on the market. This program discusses 510(k) thoroughly including w ...
Keywords 510(k) process
Administrative procedures
Diagnostic equipment
Medical devices
Medical equipment
Notification procedures
Prosthetic equipment
Regulations
Reviewing
US FDA
 
Please call 1-800-553-6847 or 703-605-6000 to order (NTIS Order Number AVA16114-VNB1).
Source Agency Office of Communication Media Center for Devices and Radiological Health - FDA - Audiovisual
NTIS Subject Category 95A - Prosthetics & Mechanical Organs
95C - Biomedical Instrumentation & Bioengineering
92D - Education, Law, & Humanities
Corporate Author Food and Drug Administration, Rockville, MD. Office of Communication Media Center for Devices and Radiological Health.
Document Type Audiovisual
Title Note N/A
NTIS Issue Number 0003
Contract Number N/A

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