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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K193202
Device Name EXALT Model D Single-Use Duodenoscope, EXALT Controller
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Applicant Contact Carter Navarro
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Carter Navarro
Regulation Number876.1500
Classification Product Code
FDT  
Subsequent Product Code
FET  
Date Received11/20/2019
Decision Date 12/13/2019
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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