FDA 510(k) Application Details - K010335

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K010335
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD.
700 13TH ST. NW
SUITE 1200
WASHINGTON, DC 20005 US
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Contact ROBERT DORMER
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 02/02/2001
Decision Date 09/27/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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