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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 K854594
Device Name PHOENIX U.V.A. SUNTAN BEDS
Applicant
Phoenix U.V.A. , Ltd.
413 First St.
Meservey,  IA  50457
Applicant Contact MARK GARD
Correspondent
Phoenix U.V.A. , Ltd.
413 First St.
Meservey,  IA  50457
Correspondent Contact MARK GARD
Regulation Number878.4630
Classification Product Code
FTC  
Date Received11/18/1985
Decision Date 01/30/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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