FDA 510(k) Application Details - K020032

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

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510(K) Number K020032
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant APEX MEDICAL CORP.
10TH FL., NO. 31, LANE 169,
KANG NING ST.
SHI-CHIH, TAIPEI HSIEN TW
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Contact ALAN CHANG
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/04/2002
Decision Date 01/31/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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