| 510(k) Number |
K853374 |
| Device Name |
CORRECT-A-COUNT |
| Applicant |
| Dermacare Products, Inc. |
| 7651 National Tpke. |
|
Louisville,
KT
40214
|
|
| Applicant Contact |
LARRY D POTTS |
| Correspondent |
| Dermacare Products, Inc. |
| 7651 National Tpke. |
|
Louisville,
KT
40214
|
|
| Correspondent Contact |
LARRY D POTTS |
| Date Received | 08/12/1985 |
| Decision Date | 09/05/1985 |
| 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
|
|
|