WELCH ALLYN HI - LUX ILLUMINATOR

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 Hi - Lux Illuminator.

Pre-market Notification Details

Device IDK951647
510k NumberK951647
Device Name:WELCH ALLYN HI - LUX ILLUMINATOR
ClassificationLight Source, Fiberoptic, Routine
Applicant WELCH ALLYN, INC. 4619 JORDAN RD. P.O. BOX 187 Skaneateles Falls,  NY  13153 -0187
ContactMary K Tesoro
CorrespondentMary K Tesoro
WELCH ALLYN, INC. 4619 JORDAN RD. P.O. BOX 187 Skaneateles Falls,  NY  13153 -0187
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-10
Decision Date1995-05-17

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