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FDA 510(k) Application Details - K073503
Device Classification Name
Light, Ultraviolet, Dermatological
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510(K) Number
K073503
Device Name
Light, Ultraviolet, Dermatological
Applicant
DIOMEDICS, INC.
24372 MCCLOUD CT.
LAGUNA NIGUEL, CA 92677 US
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Contact
GARY MOCNIK
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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
12/13/2007
Decision Date
01/23/2008
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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