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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 K010335
FOIA Releasable 510(k) K010335
Device Name SLENDERTONE FLEX, MODEL, 512
Applicant
BIO-MEDICAL RESEARCH, LTD.
700 13TH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Applicant Contact ROBERT DORMER
Correspondent
BIO-MEDICAL RESEARCH, LTD.
700 13TH ST. NW
SUITE 1200
WASHINGTON,  DC  20005
Correspondent Contact ROBERT DORMER
Regulation Number890.5850
Classification Product Code
NGX  
Date Received02/02/2001
Decision Date 09/27/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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