The following data is part of a premarket notification filed by Duoject Medical Systems, Inc. with the FDA for Smart-rod.
| Device ID | K070584 |
| 510k Number | K070584 |
| Device Name: | SMART-ROD |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | DUOJECT MEDICAL SYSTEMS, INC. 50 CHEMIN DE GASPE COMPLEX B-5 Bromont, CA J2l 2n8 |
| Contact | Caroline Lavoie |
| Correspondent | Caroline Lavoie DUOJECT MEDICAL SYSTEMS, INC. 50 CHEMIN DE GASPE COMPLEX B-5 Bromont, 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 | 2007-03-01 |
| Decision Date | 2008-04-02 |
| Summary: | summary |