WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS

Light Source, Fiberoptic, Routine

WELCH ALLYN, INC.

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

Pre-market Notification Details

Device IDK852951
510k NumberK852951
Device Name:WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
ClassificationLight Source, Fiberoptic, Routine
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactRobert W Becker
CorrespondentRobert W Becker
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-11
Decision Date1985-08-27

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