| 510(k) Number |
K862039 |
| Device Name |
CONCORD CARE TRAY |
| Applicant |
| Concord Laboratories, Inc. |
| Kit St. |
|
Keene,
NH
03431
|
|
| Applicant Contact |
ROBERT WHEELER |
| Correspondent |
| Concord Laboratories, Inc. |
| Kit St. |
|
Keene,
NH
03431
|
|
| Correspondent Contact |
ROBERT WHEELER |
| Date Received | 05/28/1986 |
| Decision Date | 07/03/1986 |
| 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
|
|
|