| 510(k) Number |
K854162 |
| Device Name |
SUPPORT ARM |
| Applicant |
| Healthmate, Inc. |
| 3175 Macarthur Blvd. |
|
Northbrook,
IL
60062
|
|
| Applicant Contact |
KEN WIESELMAN |
| Correspondent |
| Healthmate, Inc. |
| 3175 Macarthur Blvd. |
|
Northbrook,
IL
60062
|
|
| Correspondent Contact |
KEN WIESELMAN |
| Date Received | 10/15/1985 |
| Decision Date | 12/09/1985 |
| 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
|
|
|