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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 K182003
Device Name Lympha Press Optimal Plus
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Applicant Contact Reuven Yunger
Correspondent
Ilan Sharon,Consultant
P.O. Box 4414 (A109)
Caesarea,  IL 3088900
Correspondent Contact Ilan Sharon
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/26/2018
Decision Date 02/27/2019
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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