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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, I.V. Fluid Transfer
510(k) Number K240748
Device Name nextaro® v, 20/20
Applicant
Sfm Medical Devices GmbH
Brueckenstrasse 5
Waechtersbach,  DE 63607
Applicant Contact Olaf Broemsen
Correspondent
Sfm Medical Devices GmbH
Brueckenstrasse 5
Waechtersbach,  DE 63607
Correspondent Contact Olaf Broemsen
Regulation Number880.5440
Classification Product Code
LHI  
Date Received03/19/2024
Decision Date 04/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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