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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 K934370
Device Name BIP BIOPSY NEEDLE MODIFICATION
Applicant
BIP USA, INC.
CARBORUNDUM CENTER
SUITE 480, 345 THIRD STREET
NIAGARA FALLS,  NY  14303
Applicant Contact GARY HORNER
Correspondent
BIP USA, INC.
CARBORUNDUM CENTER
SUITE 480, 345 THIRD STREET
NIAGARA FALLS,  NY  14303
Correspondent Contact GARY HORNER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/07/1993
Decision Date 03/07/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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