SHEER THIN AROMAS YELLOW LATEX CONDOM— 510(k) K004051

Name: FDA 510(k) clearance K004051
Creator: U.S. Food and Drug Administration
Published: 2001-03-29

Substantially Equivalent

Eagle Twe, Inc.

FDA 510(k) clearance K004051 for SHEER THIN AROMAS YELLOW LATEX CONDOM, Substantially Equivalent on 2001-03-29. Applicant: Eagle Twe, Inc.. Device class: 2.

Clearance details

Applicant: Eagle Twe, Inc.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2000-12-29
Decision date: 2001-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucker, GA, US

Download summary PDF View on FDA.gov ↗

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K004036 — SHEER THIN AROMAS GREEN LATEX CONDOM2001-03-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.