| 510(k) Number |
K851206 |
| Device Name |
SHOULDER-HOLDER |
| Applicant |
| Biodynamic Technologies, Inc. |
| 727 Twenty-Third St. S. |
|
Arlington,
VA
22202
|
|
| Applicant Contact |
BREWSTER B TAYLOR |
| Correspondent |
| Biodynamic Technologies, Inc. |
| 727 Twenty-Third St. S. |
|
Arlington,
VA
22202
|
|
| Correspondent Contact |
BREWSTER B TAYLOR |
| Date Received | 03/26/1985 |
| Decision Date | 04/25/1985 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|