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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name massager, powered inflatable tube
510(k) Number K163280
Device Name RP Lite 760R
Applicant
Mego Afek AC Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Applicant Contact Ilan Sharon
Correspondent
Ilan Sharon consultant
Neot Golf A109
Caesarea,  IL 3088900
Correspondent Contact Ilan Sharon
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/21/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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