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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
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