510(k) K912158

CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY by Medical Device Inspection Co., Inc. — Product Code FOZ

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 23, 1991
Date Received
May 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type