| 510(k) Number |
K861043 |
| Device Name |
SPINAL EXCURSION METER |
| Applicant |
| Devcom, Inc. |
| 1010 Valley Forge Plz. |
|
King Of Prussia,
PA
19406
|
|
| Applicant Contact |
STEVEN GROSS |
| Correspondent |
| Devcom, Inc. |
| 1010 Valley Forge Plz. |
|
King Of Prussia,
PA
19406
|
|
| Correspondent Contact |
STEVEN GROSS |
| Date Received | 03/18/1986 |
| Decision Date | 03/28/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|