The following data is part of a premarket notification filed by Medxl Inc. with the FDA for Praxiject 0.9% Nacl.
| Device ID | K171109 |
| 510k Number | K171109 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-14 |
| Decision Date | 2017-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30682686004513 | K171109 | 000 |
| 30682686004506 | K171109 | 000 |
| 30682686004490 | K171109 | 000 |
| 30682686004483 | K171109 | 000 |
| 10682686004472 | K171109 | 000 |