510(k) K904425

MODEL 6/01 UV-B FIXTURE by Strato-Ray Co. — Product Code FTC

K904425 is an FDA 510(k) premarket notification submitted by Strato-Ray Co. for the device "MODEL 6/01 UV-B FIXTURE". The FDA issued a decision of Substantially Equivalent on November 21, 1990. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Strato-Ray Co. has at least 1 other 510(k) clearance on record.