FDA 510(k) Application Details - K012848

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

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510(K) Number K012848
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant RICH-MAR CORP.
P.O. BOX 879
INOLA, OK 74036 US
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Contact DAVID RICHARDS
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 08/23/2001
Decision Date 10/25/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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