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FDA 510(k) Application Details - K182215
Device Classification Name
Light, Ultraviolet, Dermatological
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510(K) Number
K182215
Device Name
Light, Ultraviolet, Dermatological
Applicant
Daavlin Distributing Company
205 W. Bement Street
Bryan, OH 43506 US
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Contact
Michele Thiel
Other 510(k) Applications for this Contact
Regulation Number
878.4630
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Classification Product Code
FTC
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More FDA Info for this Product Code
Date Received
08/15/2018
Decision Date
10/29/2018
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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