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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Container, I.V.
510(k) Number K250459
Device Name DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
Applicant
Technoflex SAS.
ZA de Bassilour
Bidart,  FR 64210
Applicant Contact Dominique Saint Ellier
Correspondent
mdi Consutants Inc.
55 Northern Blvd, Suite 200
Great Neck,  NY  11021
Correspondent Contact Vaibhav Rajal
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/18/2025
Decision Date 04/18/2025
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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