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510(k) K980795

UROLOGICAL BALLOON DILATATION CATHETER by Boston Scientific Corp — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1998
Date Received
March 2, 1998
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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