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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K024089
Device Name VACUFLASH BIOPSY SYSTEM
Applicant
Bip USA, Inc.
345 Third St., Suite 400
Niagara Falls,  NY  14303
Applicant Contact SIEGFRIED GRUCHOT
Correspondent
Bip USA, Inc.
345 Third St., Suite 400
Niagara Falls,  NY  14303
Correspondent Contact SIEGFRIED GRUCHOT
Regulation Number876.1075
Classification Product Code
KNW  
Date Received12/11/2002
Decision Date 03/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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