510(k) K060815

JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT by Bioform Medical, Inc. — Product Code MIX

K060815 is an FDA 510(k) premarket notification submitted by Bioform Medical, Inc. for the device "JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT". The FDA issued a decision of Substantially Equivalent on April 18, 2006. The device falls under product code MIX (System, Vocal Cord Medialization), a Class II device regulated under 21 CFR 874.3620. Bioform Medical, Inc. has at least 2 other 510(k) clearances on record.