BIOPSY NEEDLE GUIDE KIT, STERILE

Biopsy Needle

AMEDIC USA

The following data is part of a premarket notification filed by Amedic Usa with the FDA for Biopsy Needle Guide Kit, Sterile.

Pre-market Notification Details

Device IDK871467
510k NumberK871467
Device Name:BIOPSY NEEDLE GUIDE KIT, STERILE
ClassificationBiopsy Needle
Applicant AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix,  AZ  85040 -3969
ContactJack A Moore
CorrespondentJack A Moore
AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix,  AZ  85040 -3969
Product CodeFCG  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-14
Decision Date1987-08-21

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