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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 K131046
Device Name VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
Applicant
Venous Health Systems, Inc.
3270 Alpine Rd.
Portola Valley,  CA  94028
Applicant Contact RICH LAGUNA
Correspondent
Venous Health Systems, Inc.
3270 Alpine Rd.
Portola Valley,  CA  94028
Correspondent Contact RICH LAGUNA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/15/2013
Decision Date 07/18/2013
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
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