| Device Classification Name |
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
|
| 510(k) Number |
K952938 |
| Device Name |
AQUAFLO BTP HYDROGEL WOUND DRESSING |
| Applicant |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Applicant Contact |
FRANK J FUCCILE |
| Correspondent |
| Sherwood Medical Co. |
| 1915 Olive St. |
|
St. Louis,
MO
63103
|
|
| Correspondent Contact |
FRANK J FUCCILE |
| Classification Product Code |
|
| Date Received | 06/26/1995 |
| Decision Date | 12/08/1995 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|