The following data is part of a premarket notification filed by Lares Research, Inc. with the FDA for Apex Electric Handpiece System.
| Device ID | K031540 |
| 510k Number | K031540 |
| Device Name: | APEX ELECTRIC HANDPIECE SYSTEM |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | LARES RESEARCH, INC. 295 LOCKHEED AVE. Chico, CA 95973 |
| Contact | John Dahlgren |
| Correspondent | Alfredo J Quattrone CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-05-16 |
| Decision Date | 2003-06-30 |
| Summary: | summary |