FDA 510(k) Application Details - K151033

Device Classification Name Electrode, Cutaneous

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510(K) Number K151033
Device Name Electrode, Cutaneous
Applicant PHILIPS CONSUMER LIFESTYLE
1600 SUMMER STREET
STAMFORD, CT 06905 US
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Contact MARTA WALKER
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Regulation Number 882.1320

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Classification Product Code GXY
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Date Received 04/17/2015
Decision Date 07/28/2015
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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