Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K122817 |
Device Name |
SILVERLON ISLAND WOUND DRESSING |
Applicant |
ARGENTUM MEDICAL, LLC. |
810 LANDMARK DRIVE |
SUITE 126 |
GLEN BURNIE,
MD
21061
|
|
Applicant Contact |
WALT BRITTLE |
Correspondent |
ARGENTUM MEDICAL, LLC. |
810 LANDMARK DRIVE |
SUITE 126 |
GLEN BURNIE,
MD
21061
|
|
Correspondent Contact |
WALT BRITTLE |
Classification Product Code |
|
Date Received | 09/14/2012 |
Decision Date | 05/01/2014 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|