510(k) K955615

MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS by Misten Medical Corp. — Product Code ETA

K955615 is an FDA 510(k) premarket notification submitted by Misten Medical Corp. for the device "MISTEN MEDICAL TOTAL OSSICULAR REPLACEMENT PROSTHESIS". The FDA issued a decision of Substantially Equivalent on December 22, 1995. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Misten Medical Corp. has at least 3 other 510(k) clearances on record.