510(k) K090453

SILVER ALGINATE 11 WOUND DRESSING by Advanced Medical Solutions Limited — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 2009
Date Received
February 23, 2009
Clearance Type
Special
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