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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K192411
Device Name Psoria-Shield AURORA
Applicant
Psoria-Shield
409 Mandeville St
Utica,  NY  13502
Applicant Contact John Yorke
Correspondent
Psoria-Shield
409 Mandeville St
Utica,  NY  13502
Correspondent Contact John Yorke
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/04/2019
Decision Date 07/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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