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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 K122609
Model FLS-0003; FLS-0002; FLS-0004
Device Name VASCULAIRE COMPRESSION SYSTEM MODEL FLS-0003; VASCULAIRE SLEEVE (FOOT & CALF) MODEL FLS-0002; VASCULAIRE SLEEVE (CALF) F
Original Applicant
VENOUS HEALTH SYSTEMS, INC.
3270 alpine rd
portola valley,  CA  94028
Original Contact rich laguna
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/27/2012
Decision Date 12/21/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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