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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 K231533
Device Name Habib EndoHPB
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact Carter Navarro
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact Carter Navarro
Regulation Number876.4300
Classification Product Code
KNS  
Date Received05/26/2023
Decision Date 06/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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