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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Submucosal Injection Agent
510(k) Number K180068
Device Name ORISE Gel
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 Jennifer Edouard
Regulation Number876.1500
Classification Product Code
PLL  
Date Received01/09/2018
Decision Date 09/28/2018
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
Recalls CDRH Recalls
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