| Device Classification Name |
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
|
| 510(k) Number |
K901234 |
| Device Name |
KIRSCHNER BLADE PLATE SYSTEM OR R.A.B. BLADE PLATE |
| Applicant |
| Kirschner Medical Corp. |
| 9690 Deereco Rd.D |
|
Timonium,
MD
21093
|
|
| Applicant Contact |
SAM SON |
| Correspondent |
| Kirschner Medical Corp. |
| 9690 Deereco Rd.D |
|
Timonium,
MD
21093
|
|
| Correspondent Contact |
SAM SON |
| Regulation Number | 888.3030 |
| Classification Product Code |
|
| Date Received | 03/14/1990 |
| Decision Date | 10/04/1990 |
| 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
|
|
|