45 Micron Polyisoprene Condom— 510(k) K231908

Substantially Equivalent

Suretex Limited

FDA 510(k) clearance K231908 for 45 Micron Polyisoprene Condom, Substantially Equivalent on 2023-10-27. Applicant: Suretex Limited. Device class: 2.

Clearance details

Applicant: Suretex Limited
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2023-06-29
Decision date: 2023-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tambon Khao Kwai, Amphur Phunphin, 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.