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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Irrigation/Suction System
510(k) Number K130909
Device Name GATEWAY ADVANAGE Y-ADAPTER
Applicant
Boston Scientific Corp
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact CHRISTINE SHOEMAKER
Correspondent
Boston Scientific Corp
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact CHRISTINE SHOEMAKER
Regulation Number876.1500
Classification Product Code
OCX  
Date Received04/01/2013
Decision Date 05/16/2013
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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