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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 K012994
Device Name WIZAIR DVT
Applicant
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact SHOSHANA FRIEDMAN
Correspondent
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact SHOSHANA FRIEDMAN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/06/2001
Decision Date 03/27/2002
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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