FDA 510(k) Application Details - K032994

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

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510(K) Number K032994
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant GEMORE TECHNOLOGY CO., LTD.
11 FL, NO. 29-5, SEC. 2
CHUNG CHENG E. RD.
TAN SHUI, TAIPEI HSIEN TW
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Contact BODEN S.P. LAI
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 09/25/2003
Decision Date 12/16/2003
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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