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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name biopsy needle
510(k) Number K871467
Device Name BIOPSY NEEDLE GUIDE KIT, STERILE
Applicant
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Applicant Contact JACK A MOORE
Correspondent
AMEDIC USA
3702 EAST ROESER RD, STE
27,P.O.B.62404
PHOENIX,  AZ  85040 -3969
Correspondent Contact JACK A MOORE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/14/1987
Decision Date 08/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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