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FDA 510(k) Application Details - K230076
Device Classification Name
Light, Ultraviolet, Dermatological
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510(K) Number
K230076
Device Name
Light, Ultraviolet, Dermatological
Applicant
Psoria-Shield, Inc.
409 Mandeville St
Utica, NY 13502 US
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Contact
John Yorke
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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
01/10/2023
Decision Date
03/08/2023
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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