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510(k) K171346

Sapphire Sets by Icu Medical — Product Code MRZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2017
Date Received
May 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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