UNIVERSAL CUSHIONED METAL EYE SHIELD

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

P.J. PRODUCTS, INC.

The following data is part of a premarket notification filed by P.j. Products, Inc. with the FDA for Universal Cushioned Metal Eye Shield.

Pre-market Notification Details

Device IDK940213
510k NumberK940213
Device Name:UNIVERSAL CUSHIONED METAL EYE SHIELD
ClassificationShield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear)
Applicant P.J. PRODUCTS, INC. 8535 WEST BELLFORT Houston,  TX  77071
ContactJoel H Goffman
CorrespondentJoel H Goffman
P.J. PRODUCTS, INC. 8535 WEST BELLFORT Houston,  TX  77071
Product CodeHOY  
CFR Regulation Number886.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-14
Decision Date1994-03-24

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