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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 K850042
Device Name SOLAR TAN - SOLARIA IV
Applicant
Sola-Tan Intl.
1101 Enterprise Ave.
Box 9
Oklahoma,  OK  73128
Applicant Contact HOLLY D BRIDWELL
Correspondent
Sola-Tan Intl.
1101 Enterprise Ave.
Box 9
Oklahoma,  OK  73128
Correspondent Contact HOLLY D BRIDWELL
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/07/1985
Decision Date 01/14/1985
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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