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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 K042464
Device Name V-CORE FULL CORE BREAST BIOPSY INSTRUMENT
Applicant
Medical Device Technologies, Inc.
241 W Palatine Rd.
Wheeling,  IL  60090
Applicant Contact NICOHL WILDING
Correspondent
Medical Device Technologies, Inc.
241 W Palatine Rd.
Wheeling,  IL  60090
Correspondent Contact NICOHL WILDING
Regulation Number876.1075
Classification Product Code
KNW  
Date Received09/13/2004
Decision Date 09/30/2004
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
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