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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 K141910
Device Name Intraosseous Cannula System Bio-MAC¿ and Bio-CORE
Applicant
BIOLOGIC THERAPIES INC
3150 E. 200TH ST.
PRIOR LAKE,  MN  55372
Applicant Contact AL LIPPINCOTT
Correspondent
BIOLOGIC THERAPIES INC
5817 NW 44th Ave
Ocala,  FL  34482
Correspondent Contact Stephen Inglese
Regulation Number876.1075
Classification Product Code
KNW  
Subsequent Product Code
FCG  
Date Received07/15/2014
Decision Date 05/04/2015
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
Recalls CDRH Recalls
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