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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
Applicant
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
117 AHUZAH ST.
RA'ANANNA 43373,  IL 43373
Applicant Contact JONATHAN S KAHAN
Correspondent
MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD.
117 AHUZAH ST.
RA'ANANNA 43373,  IL 43373
Correspondent 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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