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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name saline, vascular access flush
510(k) Number K171109
Device Name Praxiject 0.9% NaCl
MedXL Inc.
285 Av Labrosse
Pointe-Claire,  CA H9R 1A3
Applicant Contact Premala Premanathan
MedXL Inc.
285 Av Labrosse
Pointe-Claire,  CA H9R 1A3
Correspondent Contact Premala Premanathan
Regulation Number880.5200
Classification Product Code
Date Received04/14/2017
Decision Date 12/21/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No