One Touch Condom with Benzocaine— 510(k) K171213

Name: FDA 510(k) clearance K171213
Creator: U.S. Food and Drug Administration
Published: 2018-01-12

Substantially Equivalent

Thai Nippon Rubber Industry Public Company Limited.

FDA 510(k) clearance K171213 for One Touch Condom with Benzocaine, Substantially Equivalent on 2018-01-12. 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: 2017-04-25
Decision date: 2018-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangkok, 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.