CICA-CARE SILICONE GEL SHEET— 510(k) K935803

Name: FDA 510(k) clearance K935803
Creator: U.S. Food and Drug Administration
Published: 1994-02-03

Substantially Equivalent

Smith & Nephew United, Inc.

FDA 510(k) clearance K935803 for CICA-CARE SILICONE GEL SHEET, Substantially Equivalent on 1994-02-03. Applicant: Smith & Nephew United, Inc.. Device class: 1.

Clearance details

Applicant: Smith & Nephew United, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1993-12-02
Decision date: 1994-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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