Device Classification Name |
Orthodontic Software
|
510(k) Number |
K193390 |
Device Name |
CS Model+ |
Applicant |
Trophy |
4 Rue F. Pelloutier |
Croissy-Beaubourg,
FR
77435
|
|
Applicant Contact |
Marie-Pierre Labat-Camy |
Correspondent |
Trophy |
4 Rue F. Pelloutier |
Croissy-Beaubourg,
FR
77435
|
|
Correspondent Contact |
Marie-Pierre Labat-Camy |
Regulation Number | 872.5470 |
Classification Product Code |
|
Date Received | 12/06/2019 |
Decision Date | 04/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|