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510(k) K192414

Device
Praxiject 0.9% NaCl
Applicant
MedXL Inc.
510(k) number
K192414
Product code
NGT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-13
Date received
2019-09-04
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
Premala Premanathan
Address
285 Av Labrosse Pointe-Claire CA H9R 1A3 H9R 1A3

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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