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FDA 510(k) Application Details - K111049
Device Classification Name
Light, Ultraviolet, Dermatological
More FDA Info for this Device
510(K) Number
K111049
Device Name
Light, Ultraviolet, Dermatological
Applicant
MEDTEK LIGHTING CORP
1131 ANTHEM VIEW LANE
KNOXVILLE, TN 37922 US
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Contact
ROBERT WAGNER
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
04/15/2011
Decision Date
05/25/2012
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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