UNIDIRECTIONAL OCCLUDER

Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)

WELCH ALLYN, INC.

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

Pre-market Notification Details

Device IDK913230
510k NumberK913230
Device Name:UNIDIRECTIONAL OCCLUDER
ClassificationShield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Applicant WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
ContactCraig Mullin
CorrespondentCraig Mullin
WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls,  NY  13153 -0220
Product CodeHOY  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-22
Decision Date1991-10-02

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