LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM— 510(k) K000408

Name: FDA 510(k) clearance K000408
Creator: U.S. Food and Drug Administration
Published: 2000-04-19

Substantially Equivalent

Suretex Prophylactics , Ltd.

FDA 510(k) clearance K000408 for LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM, Substantially Equivalent on 2000-04-19. Applicant: Suretex Prophylactics , Ltd.. Device class: 2.

Clearance details

Applicant: Suretex Prophylactics , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2000-02-08
Decision date: 2000-04-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Dothan, AL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K000408

K-number listed on FDA's recall record

Z-0717-2013 — Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.Class II·Terminated·Ansell Healthcare Products LLC·20121105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K000408.

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