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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 K190493
Device Name Recovery Pump, 737R (RPX)
Applicant
Mego Afek AC , Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Applicant Contact Reuven Yunger
Correspondent
Mego Afek AC , Ltd.
Kibbutz Afek
Kibbutz Afek,  IL 3004200
Correspondent Contact Reuven Yunger
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/28/2019
Decision Date 05/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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