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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 K160648
Device Name MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
Applicant
UNOMEDICAL A/S
AAHOLMVEJ 1-3
OSTED,  DK 4320
Applicant Contact John M Lindskog
Correspondent
UNOMEDICAL A/S
AAHOLMVEJ 1-3, OSTED
ROSKILDE,  DK DK-4320
Correspondent Contact Cindie Vandfeldt
Regulation Number880.5440
Classification Product Code
FPA  
Date Received03/07/2016
Decision Date 08/10/2016
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
Recalls CDRH Recalls
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