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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K173400
Device Name ORISE Tissue Retractor System
Applicant
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Thomas Hirte
Correspondent
Boston Scientific
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Thomas Hirte
Regulation Number876.1500
Classification Product Code
FED  
Subsequent Product Codes
GAD   ODB  
Date Received10/31/2017
Decision Date 02/09/2018
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
Predetermined Change
Control Plan Authorized		 No
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