FDA 510(k) Application Details - K151795

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K151795
Device Name Light, Ultraviolet, Dermatological
Applicant DAAVLIN DISTRIBUTING CO.
205 WEST BEMENT ST.
BRYAN, OH 43506 US
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Contact MICHELE THIEL
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Regulation Number 878.4630

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Classification Product Code FTC
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Date Received 07/02/2015
Decision Date 09/10/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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