| Device Classification Name |
Fixation Accessory
|
| 510(k) Number |
K902676 |
| Device Name |
MICROGUARD, ORTHOPEDIC PIN PROTECTORS |
| 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 | 888.3030 |
| Classification Product Code |
|
| Date Received | 06/19/1990 |
| Decision Date | 09/14/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Orthopedic
|
| 510k Review Panel |
Orthopedic
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|