FDA 510(k) Application Details - K090951

Device Classification Name Electrode, Cutaneous

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510(K) Number K090951
Device Name Electrode, Cutaneous
Applicant RS MEDICAL
14401 S.E. FIRST ST.
VANCOUVER, WA 98684 US
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Contact TIMOTHY JOHNSON
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 04/03/2009
Decision Date 06/05/2009
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 Y
Expedited Review



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