510(k) K961085

DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING by Debusk Knitting Mills, Div. Deroyal Industries — Product Code MGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1996
Date Received
March 19, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type