| Device Classification Name |
Dressing, Wound, Drug
|
| 510(k) Number |
K894541 |
| Device Name |
CARRINGTON DERMAL WOUND GEL |
| Applicant |
| Carrington Laboratories, Inc. |
| 9200 Carpenter Fwy. |
|
Dallas,
TX
75247
|
|
| Applicant Contact |
BILL H MCANALLEY |
| Correspondent |
| Carrington Laboratories, Inc. |
| 9200 Carpenter Fwy. |
|
Dallas,
TX
75247
|
|
| Correspondent Contact |
BILL H MCANALLEY |
| Classification Product Code |
|
| Date Received | 07/20/1989 |
| Decision Date | 11/30/1989 |
| 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
|
|
|