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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 K023573
Device Name WIZAIR COMPRESSION SYSTEM
Applicant
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Applicant Contact ARAVA HACOHEN
Correspondent
Medical Compression Systems (Dbn) , Ltd.
117 Ahuzah St.
Ra'Ananna 43373,  IL 43373
Correspondent Contact ARAVA HACOHEN
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/24/2002
Decision Date 11/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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