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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Pump, Infusion
510(k) Number K171346
Device Name Sapphire Sets
Applicant
Icu Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Applicant Contact Andrea Doyle
Correspondent
Icu Medical
600 N. Field Dr.
Lake Forest,  IL  60045
Correspondent Contact Amy Giertych
Regulation Number880.5725
Classification Product Code
MRZ  
Date Received05/08/2017
Decision Date 08/25/2017
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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