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510(k) K260988

°M Warmer System with °M Station by Mequ A/S — Product Code LGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2026
Date Received
March 25, 2026
Clearance Type
Special
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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