The following data is part of a premarket notification filed by Pharmajet, Inc. with the FDA for Pharmajet 0.1 Ml Intradermal Needle-free Injection System.
| Device ID | K110456 |
| 510k Number | K110456 |
| Device Name: | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | PHARMAJET, INC. 400 CORORATE CIRCLE, SUITE N Golden, CO 80401 |
| Contact | Michael J Ryan |
| Correspondent | Jeff D Rongero UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-02-16 |
| Decision Date | 2011-03-02 |
| Summary: | summary |