510(k) K984204

SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP by Argentum International, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2007
Date Received
November 24, 1998
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