510(k) K873287

IRRIGATION TRAY (W/120CC OF STERILE NORMAL SALINE) by Todd Medical, Inc. — Product Code KOD

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
November 13, 1987
Date Received
August 17, 1987
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