FDA 510(k) Application Details - K052969

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

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510(K) Number K052969
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH, LTD.
PARKMORE BUSINESS PARK WEST
GALWAY IE
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Contact MICHAEL O'SULLIVAN
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 10/21/2005
Decision Date 11/16/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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