510(k) K792028

OTOTOME BUR by American Sterilizer Co. — Product Code EQJ

K792028 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "OTOTOME BUR". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code EQJ (Bur, Ear, Nose And Throat), a Class I device regulated under 21 CFR 874.4140. American Sterilizer Co. has at least 10 other 510(k) clearances on record.