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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 K122649
Device Name NAVIGATOR HD URETERAL ACCESS SHEATH SET
Original Applicant
BOSTON SCIENTIFIC CORP.
100 boston scientific way
marlborough,  MA  01752
Original Contact huda yusuf
Regulation Number876.1500
Classification Product Code
FED  
Date Received08/30/2012
Decision Date 12/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Gastroenterology/Urology
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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