FDA.reportPublic FDA data

510(k) K233623

Device
Praxiject? SP 0.9% NaCl
Applicant
Medxl, Inc.
510(k) number
K233623
Product code
NGT
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-27
Date received
2023-11-13
Regulation
880.5200
Classification name
Saline, Vascular Access Flush
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Faiza Benazza
Address
285 Ave. Labrosse Pointe-Claire CA H9R 1A3 H9R 1A3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF