| Device Classification Name |
Plate, Fixation, Bone
|
| 510(k) Number |
K843370 |
| Device Name |
IMSI/METRIPOND GRIPPER PLATE |
| Applicant |
| Intl. Management Services, Inc. |
| 134 So. 13th. St. |
| Suite 1101 |
|
Lincoln ,
NE
68508
|
|
| Applicant Contact |
TED L ALGAIER |
| Correspondent |
| Intl. Management Services, Inc. |
| 134 So. 13th. St. |
| Suite 1101 |
|
Lincoln ,
NE
68508
|
|
| Correspondent Contact |
TED L ALGAIER |
| Regulation Number | 888.3030 |
| Classification Product Code |
|
| Date Received | 08/28/1984 |
| Decision Date | 01/23/1985 |
| 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
|
|
|