510(k) K941499

KIT PAK DRESSING CHANGE TRAY by Kit Pak, Inc. — Product Code KGX

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 20, 1994
Date Received
March 29, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type