FDA 510(k) Application Details - K070807

Device Classification Name Electrode, Cutaneous

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510(K) Number K070807
Device Name Electrode, Cutaneous
Applicant PEPIN MFG., INC.
800 LEVANGER LANE
STOUGHTON, WI 53589 US
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Contact Gary Syring
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 03/26/2007
Decision Date 05/23/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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