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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 K183187
Device Name nextaro Transfer System, nextaro va
Applicant
Sfm Medical Devices GmbH
Brueckenstrasse 5
Waechtersbach,  DE 63607
Applicant Contact Olaf Brömsen
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Mark Job
Regulation Number880.5440
Classification Product Code
LHI  
Date Received11/19/2018
Decision Date 03/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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