The following data is part of a premarket notification filed by Equidyne Systems, Inc. with the FDA for Hypex(tm) Jet Injector.
| Device ID | K945873 |
| 510k Number | K945873 |
| Device Name: | HYPEX(TM) JET INJECTOR |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | EQUIDYNE SYSTEMS, INC. 924 CALLE NEGOCIO, SUITE A San Clemente, CA 92673 |
| Contact | James Barley |
| Correspondent | James Barley EQUIDYNE SYSTEMS, INC. 924 CALLE NEGOCIO, SUITE A San Clemente, CA 92673 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-01 |
| Decision Date | 1995-08-18 |