FDA 510(k) Application Details - K080298

Device Classification Name Electrode, Cutaneous

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510(K) Number K080298
Device Name Electrode, Cutaneous
Applicant COMPLETE PRODUCT RESOURCES
92 ARGONAUT # 200
ALISO VIEJO, CA 92656 US
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Contact JOHN WALSH
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 02/05/2008
Decision Date 08/05/2008
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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