510(k) K993234

MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Micromedics, Inc. — Product Code ETB

K993234 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on November 10, 1999. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Micromedics, Inc. has at least 10 other 510(k) clearances on record.