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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 K162812
Device Name Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Se
Applicant
UNOMEDICAL A/S
AAHOLMVEJ 1-3
OSTED,  DK DK-4000
Applicant Contact John M. Lindskog
Correspondent
P/L BIOMEDICAL
10882 STONINGTON AVENUE
FORT MYERS,  FL  33913
Correspondent Contact LEE LEICHTER
Regulation Number880.5440
Classification Product Code
FPA  
Date Received10/06/2016
Decision Date 11/01/2017
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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