GUARDIAN GEL, SURGEON'S GLOVING CREAM

Cream, Gloving, Surgeon's

GUARDIAN ANGEL PRODUCTS, INC.

The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Guardian Gel, Surgeon's Gloving Cream.

Pre-market Notification Details

Device IDK910687
510k NumberK910687
Device Name:GUARDIAN GEL, SURGEON'S GLOVING CREAM
ClassificationCream, Gloving, Surgeon's
Applicant GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington,  DC  20004
ContactHoward M Holstein
CorrespondentHoward M Holstein
GUARDIAN ANGEL PRODUCTS, INC. COLUMBIA SQUARE 555 THIRTEETH STREET NW Washington,  DC  20004
Product CodeKGQ  
CFR Regulation Number878.4470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-19
Decision Date1991-10-11

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