FDA 510(k) Application Details - K030375

Device Classification Name Electrode, Cutaneous

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510(K) Number K030375
Device Name Electrode, Cutaneous
Applicant PAIN MANAGEMENT TECHNOLOGIES
43 E. MARKET ST.
AKRON, OH 44308 US
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Contact JOSHUA LEFKOVITZ
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 02/04/2003
Decision Date 05/05/2003
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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