510(k) K896729

NELATON-, FEMALE - OR TIEMANN CATHETER by Unoplast A/S — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1990
Date Received
November 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type