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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 K113525
Device Name ACTIVECARE DVT ACTIVECARE+SFT
Original Applicant
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
117 ahuzah st.
ra'ananna 43373,  IL 43373
Original Contact jonathan s kahan
Regulation Number870.5800
Classification Product Code
JOW  
Date Received11/29/2011
Decision Date 01/31/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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