510(k) K812543

TANARAMA by Marketing Consultants of America — Product Code FTC

K812543 is an FDA 510(k) premarket notification submitted by Marketing Consultants of America for the device "TANARAMA". The FDA issued a decision of Substantially Equivalent on October 8, 1981. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Marketing Consultants of America has at least 1 other 510(k) clearance on record.