510(k) K991324

TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE) by Heinz Kurz — Product Code KHJ

K991324 is an FDA 510(k) premarket notification submitted by Heinz Kurz for the device "TITANIUM VOCAL FOLD MEDIALIZING IMPLANT, MODELS 5001 001 (FEMALE), AND 5001 003 (MALE)". The FDA issued a decision of Substantially Equivalent on May 18, 1999. 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. Heinz Kurz has at least 4 other 510(k) clearances on record.