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FDA 510(k) Application Details - K080304
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K080304
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
WELL-LIFE HEALTHCARE LIMITED
1FL, NO.16, LANE 454
JUNGJENG RD.
YUNGHE CITY, TAIPEI COUNTY TW
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Contact
JENNY HSIEH
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
GZJ
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More FDA Info for this Product Code
Date Received
02/05/2008
Decision Date
06/20/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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