NEEDLE-GRABBER

Guide, Needle, Surgical

GUARDIAN ANGEL PRODUCTS, INC.

The following data is part of a premarket notification filed by Guardian Angel Products, Inc. with the FDA for Needle-grabber.

Pre-market Notification Details

Device IDK923840
510k NumberK923840
Device Name:NEEDLE-GRABBER
ClassificationGuide, Needle, Surgical
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 CodeGDF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-31
Decision Date1993-07-13

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