510(k) K231754

Device: Praxiject? 0.9% NaCl
Applicant: Medxl, Inc.
510(k) number: K231754
Product code: NGT
Decision: Substantially Equivalent (SESE)
Decision date: 2023-07-13
Date received: 2023-06-15
Regulation: 880.5200
Classification name: Saline, Vascular Access Flush
Medical specialty: General Hospital
Review panel: General Hospital
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Hina Saini
Address: 285 Ave. Labrosse Pointe-Claire CA H9R 1A3 H9R 1A3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF