PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER)— 510(k) K091011

Name: FDA 510(k) clearance K091011
Creator: U.S. Food and Drug Administration
Published: 2009-04-22

Substantially Equivalent

Surgical Technology Laboratories, Inc ("Stl")

FDA 510(k) clearance K091011 for PUREFORM EPTFE FACIAL IMPLANTS (NASAL, CHIN, MALER), Substantially Equivalent on 2009-04-22. Applicant: Surgical Technology Laboratories, Inc ("Stl"). Device class: 2.

Clearance details

Applicant: Surgical Technology Laboratories, Inc ("Stl")
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 2009-04-09
Decision date: 2009-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, SC, US

Download summary PDF View on FDA.gov ↗

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