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FDA 510(k) Application Details - K970429
Device Classification Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
More FDA Info for this Device
510(K) Number
K970429
Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant
APEX MEDICAL CORP.
10TH FLOOR, NO.31, LANE 169
KANG NING STREET
HSI-CHIH CITY, TAIPEI HSIEN TW
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Contact
DANIEL LEE
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
02/04/1997
Decision Date
04/29/1997
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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