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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K061866
Device Name NANOTHERM, VASCUTHERM AND PROTHERMO THERAPY WRAPS
Applicant
Thermotek, Inc.
1454 Halsey Way
Carrollton,  TX  75007
Applicant Contact TONY QUISENBERRY
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number870.5800
Classification Product Code
JOW  
Subsequent Product Code
ILO  
Date Received07/03/2006
Decision Date 08/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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