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 |