SILHOUETTE MALAR IMPLANT— 510(k) K944165

Name: FDA 510(k) clearance K944165
Creator: U.S. Food and Drug Administration
Published: 1994-11-04

Substantially Equivalent

Spectrum Designs, Inc.

FDA 510(k) clearance K944165 for SILHOUETTE MALAR IMPLANT, Substantially Equivalent on 1994-11-04. Applicant: Spectrum Designs, Inc.. Device class: 2.

Clearance details

Applicant: Spectrum Designs, Inc.
Product code: Code LZK
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1994-08-26
Decision date: 1994-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, 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.