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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 K180037
Device Name Beacon EUS Access System
Applicant
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Applicant Contact Rachel Silva
Correspondent
Covidien llc
15 Hampshire Street
Mansfield,  MA  02048
Correspondent Contact Rachel Silva
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/05/2018
Decision Date 04/26/2018
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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