The following data is part of a premarket notification filed by Medi-ject Corp. with the FDA for Medi-ject Corporation Medi-jector Needle-free Bio-tropin Ddrug Delivery Systems 0.0058/0.0068(inch Diameter Nozzleorific.
| Device ID | K960285 |
| 510k Number | K960285 |
| Device Name: | MEDI-JECT CORPORATION MEDI-JECTOR NEEDLE-FREE BIO-TROPIN DDRUG DELIVERY SYSTEMS 0.0058/0.0068(INCH DIAMETER NOZZLEORIFIC |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | MEDI-JECT CORP. 1840 BERKSHIRE LN. Minneapolis, MN 55441 |
| Contact | Peter Sadowski, Ph.d. |
| Correspondent | Peter Sadowski, Ph.d. MEDI-JECT CORP. 1840 BERKSHIRE LN. Minneapolis, MN 55441 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-19 |
| Decision Date | 1996-04-17 |
| Summary: | summary |