Device Classification Name |
aligner, sequential
|
510(k) Number |
K093821 |
Device Name |
FS ALIGNER |
Applicant |
ALLESEE ORTHODONTIC APPLIANCES |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Applicant Contact |
Wendy Garman |
Correspondent |
ALLESEE ORTHODONTIC APPLIANCES |
1717 WEST COLLINS AVENUE |
ORANGE,
CA
92867
|
|
Correspondent Contact |
Wendy Garman |
Regulation Number | 872.5470
|
Classification Product Code |
|
Date Received | 12/14/2009 |
Decision Date | 08/27/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|