FDA 510(k) Application Details - K052182

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

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510(K) Number K052182
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant SHIAN JIA MEEI ENTERPRISE CO., LTD.
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 08/10/2005
Decision Date 11/04/2005
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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