RADIESSE LARYNGEAL IMPLANT— 510(k) K070090

Name: FDA 510(k) clearance K070090
Creator: U.S. Food and Drug Administration
Published: 2007-03-01

Substantially Equivalent

Bioform Medical, Inc.

FDA 510(k) clearance K070090 for RADIESSE LARYNGEAL IMPLANT, Substantially Equivalent on 2007-03-01. Applicant: Bioform Medical, Inc.. Device class: 2.

Clearance details

Applicant: Bioform Medical, Inc.
Product code: Code MIX
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2007-01-10
Decision date: 2007-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.