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510(k) K173516

NuBorne Infant Warmer by International Biomedical — Product Code FMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2018
Date Received
November 14, 2017
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Infant Radiant
Device Class
Class II
Regulation Number
880.5130
Review Panel
HO
Submission Type

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