Device Classification Name |
handpiece, air-powered, dental
|
510(k) Number |
K000049 |
Device Name |
SUNI MAX |
Applicant |
SATELEC |
70 WALNUT ST. |
WELLESLEY,
MA
02481
|
|
Applicant Contact |
JACQUELINE E MASSE |
Correspondent |
SATELEC |
70 WALNUT ST. |
WELLESLEY,
MA
02481
|
|
Correspondent Contact |
JACQUELINE E MASSE |
Regulation Number | 872.4200
|
Classification Product Code |
|
Date Received | 01/07/2000 |
Decision Date | 04/04/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|