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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 K854131
Device Name PHASE V-MODEL 1500 RUVA
Applicant
Apollo'S Suntanning Supplies
626 N. & S. Rd.
University City,  MO  63130
Applicant Contact GRETCHEN M ENGEL
Correspondent
Apollo'S Suntanning Supplies
626 N. & S. Rd.
University City,  MO  63130
Correspondent Contact GRETCHEN M ENGEL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received10/10/1985
Decision Date 11/08/1985
Decision Substantially Equivalent (SESE)
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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