The following data is part of a premarket notification filed by Intra Vantage, Inc. with the FDA for Cyberjet Local Anesthesia System.
| Device ID | K964802 |
| 510k Number | K964802 |
| Device Name: | CYBERJET LOCAL ANESTHESIA SYSTEM |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | INTRA VANTAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf INTRA VANTAGE, INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-29 |
| Decision Date | 1997-05-27 |
| Summary: | summary |