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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 K862097
Device Name FACE TANNER
Applicant
Tan America Mfg.
P. O. Box 368
1147-C Kck Way
Cedar Hill,  TX  75104
Applicant Contact JAMES W DILLARD
Correspondent
Tan America Mfg.
P. O. Box 368
1147-C Kck Way
Cedar Hill,  TX  75104
Correspondent Contact JAMES W DILLARD
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/02/1986
Decision Date 06/17/1986
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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