| 510(k) Number |
K852891 |
| Device Name |
SPINAL FIXATION INSTRUMENTATION SYSTEM |
| Applicant |
| Buckman Co., Inc. |
| 921 Calle Verde |
|
Martinez,
CA
94553
|
|
| Applicant Contact |
DAVID W SCHLERG |
| Correspondent |
| Buckman Co., Inc. |
| 921 Calle Verde |
|
Martinez,
CA
94553
|
|
| Correspondent Contact |
DAVID W SCHLERG |
| Date Received | 07/09/1985 |
| Decision Date | 07/26/1985 |
| 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
|
|
|