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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 K103247
Device Name VASCUCOMP
Applicant
Thermotek, Inc.
1200 Lakeside Pkwy.
#200
Flower Mound,  TX  75028
Applicant Contact NIRAN BALACHANDRAN
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact WILLIAM J SAMMONS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/03/2010
Decision Date 12/10/2010
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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