| 510(k) Number |
K863271 |
| Device Name |
FASCICULATED S ROD |
| Applicant |
| The Deca Co. |
| P.O. Box 1997 |
|
Costa Mesa,
CA
92626
|
|
| Applicant Contact |
WILLIAM X HALLORAN |
| Correspondent |
| The Deca Co. |
| P.O. Box 1997 |
|
Costa Mesa,
CA
92626
|
|
| Correspondent Contact |
WILLIAM X HALLORAN |
| Date Received | 08/25/1986 |
| Decision Date | 12/24/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|