Device Classification Name |
dental stereotaxic instrument
|
510(k) Number |
K161406 |
Device Name |
Navident |
Applicant |
ClaroNav Inc. |
1140 Sheppard Avenue West, Unit 10 |
Toronto,
CA
M3K 2A2
|
|
Applicant Contact |
Doron Dekel |
Correspondent |
ClaroNav Inc. |
1140 Sheppard Avenue West, Unit 10 |
Toronto,
CA
M3K 2A2
|
|
Correspondent Contact |
Doron Dekel |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 05/20/2016 |
Decision Date | 09/08/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|