The following data is part of a premarket notification filed by Medi-ject Corp. with the FDA for Modification To Medi-ject Corporation Medi-jector Choice Needle-free Insulin Delivery System.
| Device ID | K991294 |
| 510k Number | K991294 |
| Device Name: | MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | MEDI-JECT CORP. 161 CHESHIRE LANE, SUITE 100 Minneapolis, MN 55441 |
| Contact | Peggy L Holland |
| Correspondent | Peggy L Holland MEDI-JECT CORP. 161 CHESHIRE LANE, SUITE 100 Minneapolis, MN 55441 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-15 |
| Decision Date | 1999-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640180261001 | K991294 | 000 |
| 07640180261018 | K991294 | 000 |