| 510(k) Number |
K843348 |
| Device Name |
NISONSON WIRE & DRILL GUIDE SYS |
| Applicant |
| Stryker Corp. |
| 420 Alcott St. |
|
Kalamazoo,
MI
49001
|
|
| Applicant Contact |
MARY C MASTENBROOK |
| Correspondent |
| Stryker Corp. |
| 420 Alcott St. |
|
Kalamazoo,
MI
49001
|
|
| Correspondent Contact |
MARY C MASTENBROOK |
| Date Received | 08/27/1984 |
| Decision Date | 10/31/1984 |
| 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
|
|
|