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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K192647
Device Name neria guard Infusion Set
Applicant
Unomedical a/s
Aaholmvej 1-3
Osted,  DK DK-4320
Applicant Contact Mette Busk Henningsen
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road, Building 1, Suite 300
Austin,  TX  78746
Correspondent Contact Deirdre Barrow
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/24/2019
Decision Date 12/13/2019
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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