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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K160845
FOIA Releasable 510(k) K160845
Device Name Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
Applicant
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
Marlborough,  MA  01752
Applicant Contact Yingying Gao
Correspondent
BOSTON SCIENTIFIC CORPORATION
100 BOSTON SCIENTIFIC WAY
Marlborough,  MA  01752
Correspondent Contact Yingying Gao
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received03/28/2016
Decision Date 05/03/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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