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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 K110159
Device Name ACTIVECARE SFT
Applicant
Medical Compression Systems (Dbn) , Ltd.
25a Sirkin St.
Kfar Saba,  IL 44421
Applicant Contact ORLY MAOR
Correspondent
Medical Compression Systems (Dbn) , Ltd.
25a Sirkin St.
Kfar Saba,  IL 44421
Correspondent Contact ORLY MAOR
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/19/2011
Decision Date 05/12/2011
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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