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510(k) K181775

Quantum Blood and IV Fluid Infusion Warmer by Life Warmer, Inc. — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
July 3, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Thermal, Infusion Fluid
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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