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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name choledochoscope and accessories, flexible/rigid
510(k) Number K181439
Device Name SpyGlass DS and DS II Direct Visualization System
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 Jennifer Kimball
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
KQM   NTN  
Date Received06/01/2018
Decision Date 08/23/2018
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
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