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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 K141894
FOIA Releasable 510(k) K141894
Device Name SHARKCORE FINE NEEDLE BIOPSY SYSTEM
Applicant
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP)
2000 COMMONWEALTH AVE. SUITE 110
AUBURNDALE,  MA  02466 -2008
Applicant Contact Saket Bhatt
Correspondent
COVIDIEN LLC (FORMERLY BEACON ENDOSCOPIC CORP)
2000 COMMONWEALTH AVE. SUITE 110
AUBURNDALE,  MA  02466 -2008
Correspondent Contact Saket Bhatt
Regulation Number876.1075
Classification Product Code
FCG  
Date Received07/14/2014
Decision Date 10/06/2014
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
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