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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 K141919
Device Name VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR
Applicant
AD REM TECHNOLOGY SARL
9109 COPENHAVER DRIVE
POTOMAC,  MD  20854
Applicant Contact NORMAN F ESTRIN
Correspondent
AD REM TECHNOLOGY SARL
9109 COPENHAVER DRIVE
POTOMAC,  MD  20854
Correspondent Contact NORMAN F ESTRIN
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
GXY  
Date Received07/15/2014
Decision Date 06/16/2015
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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