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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K140323
Device Name NAVIGATOR HD URETERAL ACCESS SHEATH SETS
Applicant
Boston Scientific
100 Boston Scientific Way
Marlboro,  MA  01752
Applicant Contact NICHOLE RIEK
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact NICHOLE RIEK
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/10/2014
Decision Date 03/07/2014
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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