FDA 510(k) Application Details - K021794

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

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510(K) Number K021794
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant TATUNG CO.
3892 SOUTH AMERICA WEST TRAIL
FLAGSTAFF, AZ 86001 US
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Contact JENNIFER REICH
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 05/31/2002
Decision Date 01/13/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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