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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 K963813
Device Name SURE CORE BIOPSY KIT
Applicant
Interventional Concepts, Inc.
12165 49th St. N.
Clearwater,  FL  34622
Applicant Contact WILLIAM E MCPHERSON
Correspondent
Interventional Concepts, Inc.
12165 49th St. N.
Clearwater,  FL  34622
Correspondent Contact WILLIAM E MCPHERSON
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/23/1996
Decision Date 03/20/1997
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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