Device Classification Name |
Implant, Endosseous, Root-Form
|
510(k) Number |
K855005 |
Device Name |
FIBER MESH |
Applicant |
FIBER MESH, INC. |
1465 POST RD. EAST |
WESTPORT,
CT
06880
|
|
Applicant Contact |
KENNETH J BERK |
Correspondent |
FIBER MESH, INC. |
1465 POST RD. EAST |
WESTPORT,
CT
06880
|
|
Correspondent Contact |
KENNETH J BERK |
Regulation Number | 872.3640
|
Classification Product Code |
|
Date Received | 12/13/1985 |
Decision Date | 01/30/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|