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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 K173879
Device Name MiniMed Mio Advance infusion set
Applicant
Unomedical A/S
Aaholmvej 1-3
Osted,  DK DK-4320
Applicant Contact Heidi Bjerre Lovkvist
Correspondent
Emergo Global Consulting, LLC
2500 Bee Cave Road
Bldg 1, Suite 300
Austin,  TX  78746
Correspondent Contact Deirdre Barrow
Regulation Number880.5440
Classification Product Code
FPA  
Date Received12/21/2017
Decision Date 03/05/2018
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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