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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 K233623
Device Name Praxiject™ SP 0.9% NaCl
Applicant
MedXL Inc.
285 Avenue Labrosse
Pointe-Claire,  CA H9R 1A3
Applicant Contact Faiza Benazza
Correspondent
MedXL Inc.
285 Avenue Labrosse
Pointe-Claire,  CA H9R 1A3
Correspondent Contact Faiza Benazza
Regulation Number880.5200
Classification Product Code
NGT  
Date Received11/13/2023
Decision Date 02/27/2024
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
Predetermined Change
Control Plan Authorized		 No
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