510(k) K972815

PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT by Grace Medical, Inc. — Product Code ETB

K972815 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT". The FDA issued a decision of Substantially Equivalent on October 8, 1997. 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.