Device Classification Name |
Plate, Bone
|
510(k) Number |
K953386 |
Device Name |
9I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: BONE MESH-PLATE & SCREWS |
Applicant |
IMPLANT INNOVATIONS, INC. |
3071 CONTINENTAL DR. |
WEST PALM BEACH,
FL
33407
|
|
Applicant Contact |
WILLIAM G CONETY |
Correspondent |
IMPLANT INNOVATIONS, INC. |
3071 CONTINENTAL DR. |
WEST PALM BEACH,
FL
33407
|
|
Correspondent Contact |
WILLIAM G CONETY |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 07/19/1995 |
Decision Date | 09/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|