510(k) K122817

SILVERLON ISLAND WOUND DRESSING by Argentum Medical, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2014
Date Received
September 14, 2012
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