The following data is part of a premarket notification filed by Medxl Inc. with the FDA for Praxiject 0.9% Nacl.
| Device ID | K192414 |
| 510k Number | K192414 |
| Device Name: | Praxiject 0.9% NaCl |
| Classification | Saline, Vascular Access Flush |
| Applicant | MedXL Inc. 285 Av Labrosse Pointe-claire, CA H9r 1a3 |
| Contact | Premala Premanathan |
| Correspondent | Premala Premanathan MedXL Inc. 285 Av Labrosse Pointe-claire, CA H9r 1a3 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-04 |
| Decision Date | 2020-02-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20801902214342 | K192414 | 000 |
| 20801902214892 | K192414 | 000 |
| 20682686004547 | K192414 | 000 |