Device Classification Name |
dressing, wound, drug
|
510(k) Number |
K190343 |
Device Name |
Silverlon Wound Contact, Burn Contact Dressings |
Applicant |
Argentum Medical, LLC |
2571 Kaneville CT |
geneva,
IL
60134
|
|
Applicant Contact |
aftab ahmad |
Correspondent |
Argentum Medical, LLC |
2571 Kaneville CT |
geneva,
IL
60134
|
|
Correspondent Contact |
aftab ahmad |
Classification Product Code |
|
Date Received | 02/14/2019 |
Decision Date | 07/18/2019 |
Decision |
substantially equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|