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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 K100320
Device Name SLENDERTONE SYSTEM ULTRA MODEL E70/X70
Applicant
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE
Applicant Contact DEIRDRE BARROW
Correspondent
BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK, WEST
GALWAY,  IE
Correspondent Contact DEIRDRE BARROW
Regulation Number890.5850
Classification Product Code
NGX  
Date Received02/04/2010
Decision Date 05/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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