FDA 510(k) Application Details - K010295

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

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510(K) Number K010295
Device Name Stimulator, Nerve, Transcutaneous, For Pain Relief
Applicant MICROSTIM, INC.
7881 N.W. 90TH AVE.
TAMARAC, FL 33321 US
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Contact JOEL ROSSEN
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Regulation Number 882.5890

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Classification Product Code GZJ
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Date Received 01/31/2001
Decision Date 08/03/2001
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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