| 510(k) Number |
K853759 |
| Device Name |
CUSTOM PROCEDURAL TRAY PROCEDURAL KIT |
| Applicant |
| Charles Atkins & Co. |
| 5801 Peachtree Dunwoody Rd. |
|
Atlanta,
GA
30342
|
|
| Applicant Contact |
CHARLES R ATKINS |
| Correspondent |
| Charles Atkins & Co. |
| 5801 Peachtree Dunwoody Rd. |
|
Atlanta,
GA
30342
|
|
| Correspondent Contact |
CHARLES R ATKINS |
| Date Received | 09/09/1985 |
| Decision Date | 11/17/1985 |
| Decision |
Substantially Equivalent - With Drug
(SESD) |
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|