| Device Classification Name |
Blade, Saw, Surgical, Cardiovascular
|
| 510(k) Number |
K862474 |
| Device Name |
HALL STERNUM SAW |
| Applicant |
| Hall Surgical, Division of Zimmer, Inc. |
| P.O. Box 899 |
|
`Anta Barbara,
CA
93102
|
|
| Applicant Contact |
DAVID WELLINGTON |
| Correspondent |
| Hall Surgical, Division of Zimmer, Inc. |
| P.O. Box 899 |
|
`Anta Barbara,
CA
93102
|
|
| Correspondent Contact |
DAVID WELLINGTON |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 06/30/1986 |
| Decision Date | 07/17/1986 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|