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510(k) K133750

OCCLUDER OCCLUSION BALLOON CATHETER by Boston Scientific Corporation — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2014
Date Received
December 9, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ureteral, Gastro-Urology
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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