510(k) K895814

MICROTEK PISTON & WIRE PROSTHESES by Microbio-Medics, Inc. — Product Code ETB

K895814 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "MICROTEK PISTON & WIRE PROSTHESES". The FDA issued a decision of Substantially Equivalent on December 26, 1989. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.