510(k) K885201

OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT by Microbio-Medics, Inc. — Product Code ETA

K885201 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT". The FDA issued a decision of Substantially Equivalent on April 19, 1989. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.