ANOSCOPE, OPTIC, FIBER

Anoscope And Accessories

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Anoscope, Optic, Fiber.

Pre-market Notification Details

Device IDK770906
510k NumberK770906
Device Name:ANOSCOPE, OPTIC, FIBER
ClassificationAnoscope And Accessories
Applicant WELCH ALLYN, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFER  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-05-18
Decision Date1977-06-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00732094079975 K770906 000
00732094079661 K770906 000
00732094079685 K770906 000
00732094079692 K770906 000
00732094079906 K770906 000
00732094079913 K770906 000
00732094079920 K770906 000
00732094079937 K770906 000
00732094079944 K770906 000
00732094079951 K770906 000
00732094079968 K770906 000
00732094074468 K770906 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.