The following data is part of a premarket notification filed by Asi Medical, Inc. with the FDA for Seac Advanced Dental System - Model 2001,2010 Or Model 2020.
| Device ID | K974487 |
| 510k Number | K974487 |
| Device Name: | SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 |
| Classification | Unit, Operative Dental |
| Applicant | ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood, CO 80112 |
| Contact | John W Mcpeek |
| Correspondent | John W Mcpeek ASI MEDICAL, INC. 14550 EAST EASTER AVE. SUITE 700 Englewood, CO 80112 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-26 |
| Decision Date | 1998-02-18 |