| 510(k) Number |
K853800 |
| Device Name |
UPPER-CHEST-SUPPORT CUSHION FOR OPERATIONS IN SITT |
| Applicant |
| Cedar Surgical, Inc. |
| 11 Charles Lake Rd. |
|
North Oaks,
MN
55110
|
|
| Applicant Contact |
FRED S HALVERSON |
| Correspondent |
| Cedar Surgical, Inc. |
| 11 Charles Lake Rd. |
|
North Oaks,
MN
55110
|
|
| Correspondent Contact |
FRED S HALVERSON |
| Date Received | 09/11/1985 |
| Decision Date | 10/07/1985 |
| 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
|
|
|