BIP BIOPSY NEEDLE MODIFICATION

Biopsy Needle

BIP USA, INC.

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

Pre-market Notification Details

Device IDK934370
510k NumberK934370
Device Name:BIP BIOPSY NEEDLE MODIFICATION
ClassificationBiopsy Needle
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 CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-09-07
Decision Date1994-03-07

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