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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 K241976
Device Name nextaro® va, 15mm, 5µm
Applicant
Sfm Medical Devices GmbH
Brueckenstrasse 5
Waechtersbach,  DE 63607
Applicant Contact Dr. Olaf Broemsen
Correspondent
Sfm Medical Devices GmbH
Brueckenstrasse 5
Waechtersbach,  DE 63607
Correspondent Contact Dr. Olaf Broemsen
Regulation Number880.5440
Classification Product Code
LHI  
Date Received07/05/2024
Decision Date 09/06/2024
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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