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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 K140519
Device Name RECOVERY PUMP 737R
Applicant
Mego Afek AC , Ltd.
Kibbutz Afek
Afek,  IL 30042
Applicant Contact AHARON COHEN
Correspondent
Mego Afek AC , Ltd.
Kibbutz Afek
Afek,  IL 30042
Correspondent Contact AHARON COHEN
Regulation Number890.5650
Classification Product Code
IRP  
Date Received02/28/2014
Decision Date 06/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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