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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 K210544
Device Name Medtronic Extended infusion set
Applicant
Unomedical A/S
Aaholmvej 1-3
Osted,  DK 4320
Applicant Contact Lone Sylvest Vestergaard Jepsen
Correspondent
Unomedical A/S
Aaholmvej 1-3
Osted,  DK 4320
Correspondent Contact Lone Sylvest Vestergaard Jepsen
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/24/2021
Decision Date 07/16/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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