The following data is part of a premarket notification filed by Pharmajet, Inc. with the FDA for Pharmajet Needle-free Injection System.
| Device ID | K081532 |
| 510k Number | K081532 |
| Device Name: | PHARMAJET NEEDLE-FREE INJECTION SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | PHARMAJET, INC. 221 CORPORATE CIRCLE SUITE D Golden, CO 80401 |
| Contact | Ron Bauer |
| Correspondent | Ron Bauer PHARMAJET, INC. 221 CORPORATE CIRCLE SUITE D Golden, CO 80401 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-02 |
| Decision Date | 2009-02-26 |
| Summary: | summary |