MEDICAL EYE DISPOSABLE SHIELD

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

BFD, INC.

The following data is part of a premarket notification filed by Bfd, Inc. with the FDA for Medical Eye Disposable Shield.

Pre-market Notification Details

Device IDK875302
510k NumberK875302
Device Name:MEDICAL EYE DISPOSABLE SHIELD
ClassificationShield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Applicant BFD, INC. P.O. DRAWER 909 Gardendale,  AL  35071
ContactPatrick Russell
CorrespondentPatrick Russell
BFD, INC. P.O. DRAWER 909 Gardendale,  AL  35071
Product CodeHOY  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-29
Decision Date1988-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20817583023319 K875302 000
20817583023289 K875302 000
20817583023272 K875302 000
20817583023265 K875302 000
20817583023258 K875302 000
20817583023241 K875302 000
20817583023296 K875302 000
20817583023302 K875302 000

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