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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 K142772
Device Name Phlebo Press DVT 603
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Applicant Contact Aharon Cohen
Correspondent
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Correspondent Contact Aharon Cohen
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/25/2014
Decision Date 12/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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