LX 150 LIGHT SOURCE

Source, Carrier, Fiberoptic Light

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Lx 150 Light Source.

Pre-market Notification Details

Device IDK922095
510k NumberK922095
Device Name:LX 150 LIGHT SOURCE
ClassificationSource, Carrier, Fiberoptic Light
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactLawrence E Marocco
CorrespondentLawrence E Marocco
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeEQH  
CFR Regulation Number874.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-05
Decision Date1992-07-17

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