510(k) K990601

BOJRAB MICRO-TORP, MODEL 7014-5845 by Gyrus Ent LLC — Product Code ETA

K990601 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "BOJRAB MICRO-TORP, MODEL 7014-5845". The FDA issued a decision of Substantially Equivalent on March 31, 1999. 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.