510(k) K954518

TREBAY TOTAL RECTANGULAR HEAD by Trebay Medical Corp. — Product Code ETA

K954518 is an FDA 510(k) premarket notification submitted by Trebay Medical Corp. for the device "TREBAY TOTAL RECTANGULAR HEAD". The FDA issued a decision of Substantially Equivalent on October 27, 1995. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Trebay Medical Corp. has at least 10 other 510(k) clearances on record.