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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 K163058
Device Name Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
Applicant
Boston Scientific
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact Jennifer Edouard
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Jennifer Edouard
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received11/01/2016
Decision Date 01/30/2017
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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