FDA 510(k) Application Details - K994266

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

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510(K) Number K994266
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant FUJI DYNAMICS LIMITED
UNIT 103, 23/F, LAWS PLAZA
788 CHEUNG SHA WAN RD.
KOWLOON HK
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Contact TORU HORIUCHI
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 12/17/1999
Decision Date 07/06/2000
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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