510(k) K020577

APPLIED URETERAL CATHETER by Applied Medical Resources Corp. — Product Code EYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2002
Date Received
February 21, 2002
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