The following data is part of a premarket notification filed by Feel Tech with the FDA for Feel-ject Insulin Syringe.
| Device ID | K070917 |
| 510k Number | K070917 |
| Device Name: | FEEL-JECT INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | FEEL TECH P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm FEEL TECH P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-06-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800045105652 | K070917 | 000 |
| 08800045105478 | K070917 | 000 |
| 08800045105232 | K070917 | 000 |
| 08800045105201 | K070917 | 000 |
| 08800045102538 | K070917 | 000 |
| 08800045102200 | K070917 | 000 |
| 08800045102057 | K070917 | 000 |
| 08800045101906 | K070917 | 000 |