| 510(k) Number |
K850338 |
| Device Name |
EMERGENCY ROOM PACK |
| Applicant |
| Marwood Medical, Inc. |
| Box 8712 |
|
Greensboro,
NC
27410
|
|
| Applicant Contact |
DENISE RANCK |
| Correspondent |
| Marwood Medical, Inc. |
| Box 8712 |
|
Greensboro,
NC
27410
|
|
| Correspondent Contact |
DENISE RANCK |
| Date Received | 01/28/1985 |
| Decision Date | 03/25/1985 |
| 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
|
|
|