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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, thermal regulating
510(k) Number K140078
Device Name TECOTHERM NEO (T NEO)
Applicant
INSPIRATION HEALTHCARE LTD
GILDOR HOUSE, WEST STREET
EARL SHILTON, LEICESTER,  GB LE9 7EJ
Applicant Contact WAYNE IDDON
Correspondent
INSPIRATION HEALTHCARE LTD
GILDOR HOUSE, WEST STREET
EARL SHILTON, LEICESTER,  GB LE9 7EJ
Correspondent Contact WAYNE IDDON
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received01/13/2014
Decision Date 11/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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