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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 K022855
Device Name SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511
Applicant
BIO-MEDICAL RESEARCH, LTD.
700 13TH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact ROBERT A DORMER
Correspondent
BIO-MEDICAL RESEARCH, LTD.
700 13TH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact ROBERT A DORMER
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/27/2002
Decision Date 03/06/2003
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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