SAM FACIAL IMPLANT— 510(k) K961210

Name: FDA 510(k) clearance K961210
Creator: U.S. Food and Drug Administration
Published: 1996-06-19

Substantially Equivalent

W. L. Gore & Associates, Inc.

FDA 510(k) clearance K961210 for SAM FACIAL IMPLANT, Substantially Equivalent on 1996-06-19. Applicant: W. L. Gore & Associates, Inc.. Device class: 2.

Clearance details

Applicant: W. L. Gore & Associates, Inc.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1996-03-28
Decision date: 1996-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, US

Download summary PDF View on FDA.gov ↗

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K983756 — SURGIFORM ANATOMICAL MALAR1998-11-20
K982763 — SEARE BIOMEDICAL MALAR IMPLANTS1998-09-30

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