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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 K170658
Device Name Lympha Press Optimal Plus
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Applicant Contact Reuven Yunger
Correspondent
Ilan Sharon
A 109 Neot Golf
Caesarea,  IL 3088900
Correspondent Contact Ilan Sharon
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/03/2017
Decision Date 05/31/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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