Device Classification Name |
Dental Stereotaxic Instrument
|
510(k) Number |
K182776 |
Device Name |
Neocis Guidance System |
Applicant |
Neocis Inc. |
555 NW 29th ST |
Miami,
FL
33127
|
|
Applicant Contact |
Thomas E. Claiborne |
Correspondent |
Neocis Inc. |
555 NW 29th ST |
Miami,
FL
33127
|
|
Correspondent Contact |
Thomas E. Claiborne |
Regulation Number | 872.4120
|
Classification Product Code |
|
Date Received | 10/01/2018 |
Decision Date | 12/21/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|