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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 K060146
Device Name ACTIVECARE ++ SYSTEM
Applicant
Medical Compression Systems (Dbn) , Ltd.
7 Jabotinsky St.
Moshe Aviv Tower
Ramat Gan,  IL 52520
Applicant Contact DORIT WINITZ
Correspondent
Medical Compression Systems (Dbn) , Ltd.
7 Jabotinsky St.
Moshe Aviv Tower
Ramat Gan,  IL 52520
Correspondent Contact DORIT WINITZ
Regulation Number870.5800
Classification Product Code
JOW  
Date Received01/19/2006
Decision Date 03/08/2006
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
Recalls CDRH Recalls
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