| Device Classification Name |
Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
|
| 510(k) Number |
K884492 |
| Device Name |
MICRO SURGICAL INSTRUMENT SYSTEM |
| Applicant |
| Tava Surgical Instruments |
| 7756 Burnett Ave. |
|
Van Nuys,
CA
91405
|
|
| Applicant Contact |
TERRY M MATTCHEN |
| Correspondent |
| Tava Surgical Instruments |
| 7756 Burnett Ave. |
|
Van Nuys,
CA
91405
|
|
| Correspondent Contact |
TERRY M MATTCHEN |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 10/26/1988 |
| Decision Date | 11/16/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|