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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 K103668
Device Name BNX FINE NEEDLE ASPIRATION SYSTEM
Applicant
BOSTON ENDOSCOPIC ENGINEERING
53 KENNEDY ROAD
FOSTER,  RI  02825
Applicant Contact ANNETTE M FAGNANT
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact WILLIAM SAMMONS
Regulation Number876.1075
Classification Product Code
FCG  
Date Received12/16/2010
Decision Date 12/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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