510(k) K161000

Biodesign Otologic Repair Graft by Cook Biotech Incorporated — Product Code KHJ

K161000 is an FDA 510(k) premarket notification submitted by Cook Biotech Incorporated for the device "Biodesign Otologic Repair Graft". The FDA issued a decision of Substantially Equivalent on May 11, 2016. The device falls under product code KHJ (Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)), a Class II device regulated under 21 CFR 874.3620. Cook Biotech Incorporated has at least 10 other 510(k) clearances on record.