About This 510(k) Submission
K073016 is an FDA 510(k) clearance for the TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT, a Condom (Class II — Special Controls, product code HIS), submitted by Church & Dwight Co., Inc. (Princeton, US). The FDA issued a Cleared decision on November 9, 2007, 15 days after receiving the submission on October 25, 2007. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.