WORLD'S BEST (CONTRACEPTIVE)— 510(k) K820564

Name: FDA 510(k) clearance K820564
Creator: U.S. Food and Drug Administration
Published: 1982-05-28

Substantially Equivalent

Rosen Kilde Stenhoj

FDA 510(k) clearance K820564 for WORLD'S BEST (CONTRACEPTIVE), Substantially Equivalent on 1982-05-28. Applicant: Rosen Kilde Stenhoj. Device class: 2.

Clearance details

Applicant: Rosen Kilde Stenhoj
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1982-03-02
Decision date: 1982-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom2025-11-18
K250034 — Natural rubber latex male condom2025-07-11
K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom2025-03-07
K243640 — Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)2025-02-21

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