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FDA 510(k) Application Details - K063660
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K063660
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
WELL-LIFE HEALTHCARE LIMITED
68 MODY ROAD
TSIMSHATSUIM
KOWLOON HK
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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
NUH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/08/2006
Decision Date
02/07/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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