JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT

System, Vocal Cord Medialization

BIOFORM MEDICAL, INC.

The following data is part of a premarket notification filed by Bioform Medical, Inc. with the FDA for Juliesse Injectable Laryngeal Augmentation Implant.

Pre-market Notification Details

Device IDK060815
510k NumberK060815
Device Name:JULIESSE INJECTABLE LARYNGEAL AUGMENTATION IMPLANT
ClassificationSystem, Vocal Cord Medialization
Applicant BIOFORM MEDICAL, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo,  CA  94402
ContactJames S Miller
CorrespondentJames S Miller
BIOFORM MEDICAL, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo,  CA  94402
Product CodeMIX  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-03-27
Decision Date2006-04-18
Summary:summary

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