FDA 510(k) Application Details - K021755

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

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510(K) Number K021755
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 ALAN CHANG
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 05/29/2002
Decision Date 06/12/2002
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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