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 |