FDA 510(k) Application Details - K071666

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

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510(K) Number K071666
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant BIO-MEDICAL RESEARCH CORP.
PARKMORE BUSINESS PARK WEST
GALWAY IE
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Contact ANNE-MARIE KEENAN
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 06/18/2007
Decision Date 03/12/2008
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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