| 510(k) Number |
K844072 |
| Device Name |
DERMIZIP SKIN CLOSURE DEVICE |
| Applicant |
| Kells Medical, Inc. |
| 136 Shore Dr. |
|
Burr Ridge,
IL
60521
|
|
| Applicant Contact |
JOSEPH BARROWS |
| Correspondent |
| Kells Medical, Inc. |
| 136 Shore Dr. |
|
Burr Ridge,
IL
60521
|
|
| Correspondent Contact |
JOSEPH BARROWS |
| Date Received | 10/18/1984 |
| Decision Date | 11/05/1984 |
| 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
|
|
|