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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K110057
Device Name MINI MASSEUSE
Applicant
MJ SPECIALTY RETAIL
77325 JOYCE WAY
ECHO,  OR  97826
Applicant Contact CHARLES MACK
Correspondent
MJ SPECIALTY RETAIL
77325 JOYCE WAY
ECHO,  OR  97826
Correspondent Contact CHARLES MACK
Regulation Number890.5850
Classification Product Code
NGX  
Date Received01/10/2011
Decision Date 10/28/2011
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
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