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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 K081323
Device Name BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
Applicant
B-K MEDICAL APS
MILEPARKEN 34
HERLEV,  DK DK-2730
Applicant Contact JENS RASMUSSEN
Correspondent
B-K MEDICAL APS
MILEPARKEN 34
HERLEV,  DK DK-2730
Correspondent Contact JENS RASMUSSEN
Regulation Number876.1075
Classification Product Code
FCG  
Date Received05/12/2008
Decision Date 07/22/2008
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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