DUODERM HYDROCOLLOID GEL— 510(k) K931618

Name: FDA 510(k) clearance K931618
Creator: U.S. Food and Drug Administration
Published: 1993-12-10

Substantially Equivalent

Convatec, A Division of E.R. Squibb & Sons

FDA 510(k) clearance K931618 for DUODERM HYDROCOLLOID GEL, Substantially Equivalent on 1993-12-10. Applicant: Convatec, A Division of E.R. Squibb & Sons. Device class: 1.

Clearance details

Applicant: Convatec, A Division of E.R. Squibb & Sons
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1993-04-02
Decision date: 1993-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, 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.