LARYNGEAL AUGMENTATION IMPLANT— 510(k) K033398

Substantially Equivalent

Bioform, Inc.

FDA 510(k) clearance K033398 for LARYNGEAL AUGMENTATION IMPLANT, Substantially Equivalent on 2003-12-12. Applicant: Bioform, Inc.. Device class: 2.

Clearance details

Applicant: Bioform, Inc.
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2003-10-24
Decision date: 2003-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

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