Device Classification Name |
Plate, Bone
|
510(k) Number |
K003757 |
Device Name |
THERMOFX MESH |
Applicant |
BIONX IMPLANTS, LTD. |
HERMIANKATU 6-8 L |
TAMPERE,
FI
FIN-33720
|
|
Applicant Contact |
TUIJA ANNALA |
Correspondent |
BIONX IMPLANTS, LTD. |
HERMIANKATU 6-8 L |
TAMPERE,
FI
FIN-33720
|
|
Correspondent Contact |
TUIJA ANNALA |
Regulation Number | 872.4760
|
Classification Product Code |
|
Date Received | 12/06/2000 |
Decision Date | 02/07/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|