The following data is part of a premarket notification filed by Duoject Medical Systems, Inc. with the FDA for E-z Link.
| Device ID | K133097 |
| 510k Number | K133097 |
| Device Name: | E-Z LINK |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | DUOJECT MEDICAL SYSTEMS, INC. 50 RUE DE GASPE COMPLEX B-5 Bromont, Qc., CA J2l 2n8 |
| Contact | Marie-christine Messier |
| Correspondent | Marie-christine Messier DUOJECT MEDICAL SYSTEMS, INC. 50 RUE DE GASPE COMPLEX B-5 Bromont, Qc., CA J2l 2n8 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-03-13 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() E-Z LINK 77059868 3259908 Live/Registered |
East Penn Manufacturing Co. 2006-12-08 |
![]() E-Z LINK 74497473 1916728 Dead/Cancelled |
Roadway Express, Inc. 1994-03-07 |
![]() E-Z LINK 74185878 not registered Dead/Abandoned |
Stark Truss Co., Inc. 1991-07-17 |