| Device Classification Name |
Bracket, Metal, Orthodontic
|
| 510(k) Number |
K902809 |
| Device Name |
BRACKET, METAL, ORTHODOTNIC |
| Applicant |
| Masel Industries, Inc. |
| 2701 Bartram Rd. |
|
Bristol,
PA
19007
|
|
| Applicant Contact |
THERESA MASEL |
| Correspondent |
| Masel Industries, Inc. |
| 2701 Bartram Rd. |
|
Bristol,
PA
19007
|
|
| Correspondent Contact |
THERESA MASEL |
| Regulation Number | 872.5410 |
| Classification Product Code |
|
| Date Received | 06/27/1990 |
| Decision Date | 12/07/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Dental
|
| 510k Review Panel |
Dental
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|