510(k) K963752

PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS by Grace Medical, Inc. — Product Code ETB

K963752 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on October 10, 1996. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.