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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K132110
Device Name NATUS WARMETTE BLANKET AND DUAL CABINETS
Applicant
Natus Nicolet Ireland, Ltd.
Ida Business Park
Gort, County Galway,  IE IE
Applicant Contact MICHAEL GALVIN
Correspondent
Natus Nicolet Ireland, Ltd.
Ida Business Park
Gort, County Galway,  IE IE
Correspondent Contact MICHAEL GALVIN
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received07/09/2013
Decision Date 10/03/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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