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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Infant Radiant
510(k) Number K173516
Device Name NuBorne Infant Warmer
Applicant
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Applicant Contact Amy Pieper
Correspondent
International Biomedical
8206 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact Amy Pieper
Regulation Number880.5130
Classification Product Code
FMT  
Date Received11/14/2017
Decision Date 08/17/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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