510(k) K992138

MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES by Micromedics, Inc. — Product Code ETA

K992138 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on August 9, 1999. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Micromedics, Inc. has at least 10 other 510(k) clearances on record.