Cleared Traditional

Trojan Supra Lubricated Polyurethane Male Condom

K171639 · Church & Dwight Co., Inc. · Obstetrics & Gynecology
Aug 2017
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K171639 is an FDA 510(k) clearance for the Trojan Supra Lubricated Polyurethane Male Condom, a Condom, Synthetic (Class II — Special Controls, product code MOL), submitted by Church & Dwight Co., Inc. (Ewing, US). The FDA issued a Cleared decision on August 1, 2017, 60 days after receiving the submission on June 2, 2017. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K171639 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2017
Decision Date August 01, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code MOL — Condom, Synthetic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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