510(k) K955613

MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp. — Product Code ETB

K955613 is an FDA 510(k) premarket notification submitted by Misten Medical Corp. for the device "MISTEN MEDICAL PARTIAL OSSICULAR REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Misten Medical Corp. has at least 3 other 510(k) clearances on record.