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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 K093244
Device Name UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX
Applicant
GERATHERM MEDICAL AG
SCHWARZWALDSTRASSE 5
TUTTLIGEN,  DE 78532
Applicant Contact ANDREA PECSI
Correspondent
GERATHERM MEDICAL AG
SCHWARZWALDSTRASSE 5
TUTTLIGEN,  DE 78532
Correspondent Contact ANDREA PECSI
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received10/15/2009
Decision Date 10/19/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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