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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
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