WELCH ALLYN BI-OTOSCOPE

Otoscope

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Welch Allyn Bi-otoscope.

Pre-market Notification Details

Device IDK955043
510k NumberK955043
Device Name:WELCH ALLYN BI-OTOSCOPE
ClassificationOtoscope
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactColin Wolff
CorrespondentColin Wolff
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeERA  
CFR Regulation Number874.4770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-03
Decision Date1995-11-14

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