510(k) K091187

GRACE DYNAMIC TORP by Grace Medical, Inc. — Product Code ETA

K091187 is an FDA 510(k) premarket notification submitted by Grace Medical, Inc. for the device "GRACE DYNAMIC TORP". The FDA issued a decision of Substantially Equivalent on September 14, 2009. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Grace Medical, Inc. has at least 10 other 510(k) clearances on record.