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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 K160431
Device Name ActiveCare Home
Applicant
Medical Compression Systems (Dbn) , Ltd.
12 Ha'Ilan St., P.O. Box 75
Or Akiva,  IL 30600
Applicant Contact YAKI BARAK
Correspondent
Orly Maor
25 Sirkin St.
Kfar Saba,  IL 44421
Correspondent Contact ORLY MAOR
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/16/2016
Decision Date 07/13/2016
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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