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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hyperthermia Monitor
510(k) Number K061023
Device Name THERMOSUIT SYSTEM
Applicant
Life Recovery Systems Hd, LLC
29 Anthony Ter.
Durham,  CT  06422
Applicant Contact PAUL A TENTHOREY
Correspondent
Life Recovery Systems Hd, LLC
29 Anthony Ter.
Durham,  CT  06422
Correspondent Contact PAUL A TENTHOREY
Regulation Number870.5900
Classification Product Code
NZE  
Date Received04/13/2006
Decision Date 09/20/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
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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