The following data is part of a premarket notification filed by Neocis Inc. with the FDA for Neocis Guidance System.
| Device ID | K161399 |
| 510k Number | K161399 |
| Device Name: | Neocis Guidance System |
| Classification | Dental Stereotaxic Instrument |
| Applicant | Neocis Inc. 2800 Biscayne Blvd Suite 600 Miami, FL 33137 |
| Contact | Alon Mozes |
| Correspondent | Alon Mozes 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 | 2016-05-20 |
| Decision Date | 2016-12-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20810004900008 | K161399 | 000 |
| 00810004900011 | K161399 | 000 |
| 00810004900028 | K161399 | 000 |
| 00810004900035 | K161399 | 000 |
| 00810004900042 | K161399 | 000 |
| 00810004900059 | K161399 | 000 |
| 00810004900103 | K161399 | 000 |
| 00810004900226 | K161399 | 000 |
| 00810004900240 | K161399 | 000 |
| 00810004900301 | K161399 | 000 |
| 00810004900004 | K161399 | 000 |