Device Classification Name |
mouthguard, prescription
|
510(k) Number |
K143655 |
Device Name |
SICAT OPTIMOTION |
Applicant |
SICAT GMBH & CO. KG |
BRUNNENALLEE 6 |
BONN,
DE
53177
|
|
Applicant Contact |
MANFRED BREUER |
Correspondent |
SICAT GMBH & CO. KG |
BRUNNENALLEE 6 |
BONN,
DE
53177
|
|
Correspondent Contact |
MANFRED BREUER |
Classification Product Code |
|
Date Received | 12/23/2014 |
Decision Date | 10/02/2015 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|