One Touch Spiral Condom— 510(k) K210294

Name: FDA 510(k) clearance K210294
Creator: U.S. Food and Drug Administration
Published: 2021-09-23

Substantially Equivalent

Thai Nippon Rubber Industry Public Company Limited.

FDA 510(k) clearance K210294 for One Touch Spiral Condom, Substantially Equivalent on 2021-09-23. Applicant: Thai Nippon Rubber Industry Public Company Limited.. Device class: 2.

Clearance details

Applicant: Thai Nippon Rubber Industry Public Company Limited.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2021-02-02
Decision date: 2021-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sriracha, TH

Download summary PDF View on FDA.gov ↗

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