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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 K043523
Device Name INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
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  
Subsequent Product Code
FCG  
Date Received12/20/2004
Decision Date 02/11/2005
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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