| Device Classification Name |
Blade, Saw, General & Plastic Surgery, Surgical
|
| 510(k) Number |
K896280 |
| Device Name |
MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50 |
| Applicant |
| Micro-Aire Surgical Instruments, Inc. |
| 24971 Ave. Stanford W. |
|
Valencia,
CA
91355
|
|
| Applicant Contact |
SIDDHARTH DESAI |
| Correspondent |
| Micro-Aire Surgical Instruments, Inc. |
| 24971 Ave. Stanford W. |
|
Valencia,
CA
91355
|
|
| Correspondent Contact |
SIDDHARTH DESAI |
| Regulation Number | 878.4820 |
| Classification Product Code |
|
| Date Received | 10/31/1989 |
| Decision Date | 11/22/1989 |
| 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
|
|
|