FDA 510(k) Application Details - K110390

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

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510(K) Number K110390
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant HANDELSHAUS DITTMAN GMBH
NO.3 BUILDING,XILIYIANGGUANG
INDUSTRIAL ESTATE XILLIXAOBAIM
SHENZHEN 518108 CN
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Contact KANG JIANG PING
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 02/11/2011
Decision Date 07/29/2011
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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