FDA 510(k) Application Details - K212510

Device Classification Name Light, Ultraviolet, Dermatological

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510(K) Number K212510
Device Name Light, Ultraviolet, Dermatological
Applicant Daavlin Distributing Co.
205 W. Bement Street
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 08/10/2021
Decision Date 11/04/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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