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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 K133008
Device Name BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
Applicant
Beacon Endoscopic
2000 Commonwealth Ave. Suite 110
Auburndale,  MA  02466
Applicant Contact ANNETTE M FAGNANT
Correspondent
Beacon Endoscopic
2000 Commonwealth Ave. Suite 110
Auburndale,  MA  02466
Correspondent Contact ANNETTE M FAGNANT
Regulation Number876.1075
Classification Product Code
FCG  
Date Received09/25/2013
Decision Date 11/20/2013
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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