Device Classification Name |
dental stereotaxic instrument
|
510(k) Number |
K191363 |
Device Name |
Neocis Planning Software Application (NPSA) for 3rd Party PCs |
Applicant |
Neocis Inc. |
2800 Biscayne Blvd Suite 600 |
Miami,
FL
33137
|
|
Applicant Contact |
Thomas ("Ted") E. Claiborne |
Correspondent |
Neocis Inc. |
2800 Biscayne Blvd Suite 600 |
Miami,
FL
33137
|
|
Correspondent Contact |
Thomas ("Ted") E. Claiborne |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 05/22/2019 |
Decision Date | 10/02/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|