510(k) K993840

BARD UROFORCE BALLOON DILATION CATHETER by C.R. Bard, Inc. — Product Code EZN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2000
Date Received
November 12, 1999
Clearance Type
Abbreviated
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