510(k) K091013

SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND by Advanced Medical Solutions Limited — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2009
Date Received
April 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type