FDA 510(k) Application Details - K040253

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

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510(K) Number K040253
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant EASYMED INSTRUMENT CO., LTD.
2/F-3/F, NO.2 BEIHAI DA ROAD
LUNJIAO, SHUNDE
GUANGDONG 528303 CN
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Contact WU TINGJIE
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 02/04/2004
Decision Date 04/08/2004
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 Y
Expedited Review



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