EXTERNAL BREAST PROSTHESIS— 510(k) K813416

Name: FDA 510(k) clearance K813416
Creator: U.S. Food and Drug Administration
Published: 1982-01-18

Substantially Equivalent

Surgical Appliance Industries, Inc.

FDA 510(k) clearance K813416 for EXTERNAL BREAST PROSTHESIS, Substantially Equivalent on 1982-01-18. Applicant: Surgical Appliance Industries, Inc.. Device class: 1.

Clearance details

Applicant: Surgical Appliance Industries, Inc.
Product code: Code GBI
Device class: Class 1
Regulation: 21 CFR 878.3800
Advisory panel: General, Plastic Surgery
Date received: 1981-12-07
Decision date: 1982-01-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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