BIOACCESS BONE BIOPSY SYSTEM

Instrument, Biopsy

BIOACCESS, INC.

The following data is part of a premarket notification filed by Bioaccess, Inc. with the FDA for Bioaccess Bone Biopsy System.

Pre-market Notification Details

Device IDK954151
510k NumberK954151
Device Name:BIOACCESS BONE BIOPSY SYSTEM
ClassificationInstrument, Biopsy
Applicant BIOACCESS, INC. 8400 CEDAR ST. Silver Spring,  MD  20910
ContactPeter J Carnes
CorrespondentPeter J Carnes
BIOACCESS, INC. 8400 CEDAR ST. Silver Spring,  MD  20910
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-05
Decision Date1995-09-15

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