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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 K112479
Device Name DSJ MASSAGER
Applicant
Mego Afek AC , Ltd.
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact JAMES R RAVITZ, ESQ.
Correspondent
Mego Afek AC , Ltd.
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact JAMES R RAVITZ, ESQ.
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/29/2011
Decision Date 12/07/2011
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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