510(k) K893134

APACERAM OSSICULAR PROSTHESIS by Asahi Optical Co. C/O Rosati Associates, P.C. — Product Code ETB

K893134 is an FDA 510(k) premarket notification submitted by Asahi Optical Co. C/O Rosati Associates, P.C. for the device "APACERAM OSSICULAR PROSTHESIS". The FDA issued a decision of Substantially Equivalent on August 3, 1989. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Asahi Optical Co. C/O Rosati Associates, P.C. has at least 3 other 510(k) clearances on record.