FDA 510(k) Application Details - K091045

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief

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510(K) Number K091045
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant BODY CLOCK HEALTH CARE LTD
108 GEORGE LANE
SOUTH WOODFORD, LONDON E18 1AD GB
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Contact RASHELLE PRESTON
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 04/13/2009
Decision Date 12/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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