510(k) K041243

DOVER RED RUBBER ROBINSON CATHETER by Tyco Healthcare — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 2004
Date Received
May 11, 2004
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