| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K082910 |
| Device Name |
CVS SILVER BANDAGES, WALGREENS SILVER BANDAGES, XYZ SILVER BANDAGES |
| Applicant |
| Aso, LLC |
| 962 Allegro Ln. |
|
Appollo Beach,
FL
33572
|
|
| Applicant Contact |
JONATHAN WARD |
| Correspondent |
| Aso, LLC |
| 962 Allegro Ln. |
|
Appollo Beach,
FL
33572
|
|
| Correspondent Contact |
JONATHAN WARD |
| Classification Product Code |
|
| Date Received | 09/30/2008 |
| Decision Date | 06/17/2009 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
Yes
|
Predetermined Change Control Plan Authorized |
No
|
|
|