510(k) K984207

SILVERLON DIRECT PRESSURE WOUND DRESSING by Argentum International, LLC — Product Code KMF

K984207 is an FDA 510(k) premarket notification submitted by Argentum International, LLC for the device "SILVERLON DIRECT PRESSURE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on March 19, 2007. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Argentum International, LLC has at least 7 other 510(k) clearances on record.

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
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type