510(k) K841819

CORPAK FOLEY CATH TRAY W/16FR. TEFLON by Corpak Co. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1984
Date Received
May 2, 1984
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