510(k) K001902

BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD by Gyrus Ent LLC — Product Code ETA

K001902 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "BOJRAB UNIVERSAL LONG IMLANT, MODEL TBD". The FDA issued a decision of Substantially Equivalent on July 10, 2000. The device falls under product code ETA (Replacement, Ossicular Prosthesis, Total), a Class II device regulated under 21 CFR 874.3495. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.