Synthetic Polyisoprene Lubricated Male Condom - 5 senses— 510(k) K182438

Name: FDA 510(k) clearance K182438
Creator: U.S. Food and Drug Administration
Published: 2018-12-06

Substantially Equivalent

Sxwell USA, LLC

FDA 510(k) clearance K182438 for Synthetic Polyisoprene Lubricated Male Condom - 5 senses, Substantially Equivalent on 2018-12-06. Applicant: Sxwell USA, LLC. Device class: 2.

Clearance details

Applicant: Sxwell USA, LLC
Product code: Code MOL
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2018-09-07
Decision date: 2018-12-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Iselin, NJ, US

Download summary PDF View on FDA.gov ↗

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