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FDA 510(k) Application Details - K091045
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
882.5890
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Classification Product Code
GZJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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