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 |