The following data is part of a premarket notification filed by Neocis Inc. with the FDA for Neocis Guidance System (ngs) With Fiducial Array Splint (fas).
| Device ID | K200348 |
| 510k Number | K200348 |
| Device Name: | Neocis Guidance System (NGS) With Fiducial Array Splint (FAS) |
| Classification | Dental Stereotaxic Instrument |
| Applicant | Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33137 |
| Contact | Thomas E. Claiborne |
| Correspondent | Thomas E. Claiborne Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33137 |
| Product Code | PLV |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-12 |
| Decision Date | 2020-05-08 |