The following data is part of a premarket notification filed by American Jet Injector Corp. with the FDA for Hypodermic Jet Injection Apparatus.
| Device ID | K962017 |
| 510k Number | K962017 |
| Device Name: | HYPODERMIC JET INJECTION APPARATUS |
| Classification | Injector, Jet, Mechanical-powered |
| Applicant | AMERICAN JET INJECTOR CORP. 880 ORCHARD LN. Lansdale, PA 19446 -4520 |
| Contact | Robert W Harrington |
| Correspondent | Robert W Harrington AMERICAN JET INJECTOR CORP. 880 ORCHARD LN. Lansdale, PA 19446 -4520 |
| Product Code | EGM |
| CFR Regulation Number | 872.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-23 |
| Decision Date | 1996-07-26 |