The following data is part of a premarket notification filed by Equidyne Systems, Inc. with the FDA for Jet Syringe Model-100500.
| Device ID | K003741 |
| 510k Number | K003741 |
| Device Name: | JET SYRINGE MODEL-100500 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego, CA 92128 |
| Contact | Jim Barley |
| Correspondent | Jim Barley EQUIDYNE SYSTEMS, INC. 11770 BERNARDO PLAZA CT. SUITE 351 San Diego, CA 92128 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-04 |
| Decision Date | 2001-06-01 |