FDA 510(k) Application Details - K130519

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K130519
Device Name Light, Ultraviolet, Dermatological
Applicant PHILIPS LIGHTING COMPANY
3861 SOUTH 9TH STREET
SALINA, KS 67401 US
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Contact JAMES R CYRE
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 02/27/2013
Decision Date 12/24/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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