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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K200404
Device Name ORISE ProKnife
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Jennifer Edouard
Correspondent
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Jennifer Edouard
Regulation Number876.4300
Classification Product Code
KNS  
Subsequent Product Codes
FQH   GEI  
Date Received02/19/2020
Decision Date 12/03/2020
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
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