The following data is part of a premarket notification filed by Indolor, Ltd. with the FDA for Ez-ject.
| Device ID | K051667 |
| 510k Number | K051667 |
| Device Name: | EZ-JECT |
| Classification | Introducer, Syringe Needle |
| Applicant | INDOLOR, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Contact | George J Hattub |
| Correspondent | George J Hattub INDOLOR, LTD. 291 Hillside Avenue Somerset, MA 02726 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-22 |
| Decision Date | 2005-09-27 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() EZ-JECT 87252596 5688499 Live/Registered |
Ezject, Inc. 2016-11-30 |
![]() EZ-JECT 86300060 4725358 Live/Registered |
Ezject, Inc. 2014-06-04 |
![]() EZ-JECT 77387041 not registered Dead/Abandoned |
SINDOLOR MEDICAL LTD. 2008-02-01 |