SPECTRUM DESIGNS CLEFT CHIN IMPLANT— 510(k) K980461

Name: FDA 510(k) clearance K980461
Creator: U.S. Food and Drug Administration
Published: 1998-03-04

Substantially Equivalent

Spectrum Designs, Inc.

FDA 510(k) clearance K980461 for SPECTRUM DESIGNS CLEFT CHIN IMPLANT, Substantially Equivalent on 1998-03-04. Applicant: Spectrum Designs, Inc.. Device class: 2.

Clearance details

Applicant: Spectrum Designs, Inc.
Product code: Code FWP
Device class: Class 2
Regulation: 21 CFR 878.3550
Advisory panel: General, Plastic Surgery
Date received: 1998-02-05
Decision date: 1998-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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