FACTOR II PROSTHETIC SILICONE ELASTOMER— 510(k) K880329

Name: FDA 510(k) clearance K880329
Creator: U.S. Food and Drug Administration
Published: 1988-06-01

Substantially Equivalent

Factor, Ii, Inc.

FDA 510(k) clearance K880329 for FACTOR II PROSTHETIC SILICONE ELASTOMER, Substantially Equivalent on 1988-06-01. Applicant: Factor, Ii, Inc.. Device class: 1.

Clearance details

Applicant: Factor, Ii, Inc.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1988-01-26
Decision date: 1988-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakeside, AZ, US

Download summary PDF View on FDA.gov ↗

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