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510(k) K132181

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER by Olympus Surgical Technologies America — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2013
Date Received
July 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Catheter, Ureteral
Device Class
Class II
Regulation Number
876.5470
Review Panel
GU
Submission Type

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