BIP MULTI MODIFICATION

Instrument, Biopsy

BIP USA, INC.

The following data is part of a premarket notification filed by Bip Usa, Inc. with the FDA for Bip Multi Modification.

Pre-market Notification Details

Device IDK934371
510k NumberK934371
Device Name:BIP MULTI MODIFICATION
ClassificationInstrument, Biopsy
Applicant BIP USA, INC. CARBORUNDUM CENTER SUITE 480, 345 THIRD STREET Niagara Falls,  NY  14303
ContactGary Horner
CorrespondentGary Horner
BIP USA, INC. CARBORUNDUM CENTER SUITE 480, 345 THIRD STREET Niagara Falls,  NY  14303
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-07
Decision Date1994-04-28

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