LARYNGEAL AUGMENTATION IMPLANT

System, Vocal Cord Medialization

BIOFORM, INC.

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

Pre-market Notification Details

Device IDK033398
510k NumberK033398
Device Name:LARYNGEAL AUGMENTATION IMPLANT
ClassificationSystem, Vocal Cord Medialization
Applicant BIOFORM, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo,  CA  94402
ContactJames Miller
CorrespondentJames Miller
BIOFORM, INC. 1875 SOUTH GRANT ST.,SUITE 11O San Mateo,  CA  94402
Product CodeMIX  
CFR Regulation Number874.3620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-24
Decision Date2003-12-12
Summary:summary

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