TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT

Condom

CHURCH & DWIGHT CO., INC.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Thintensity Brand Male Latex Condom Lubricated With Ultrasmooth And Warm Sensations Lubricant.

Pre-market Notification Details

• Device ID: K073016
• 510k Number: K073016
• Device Name: TROJAN THINTENSITY BRAND MALE LATEX CONDOM LUBRICATED WITH ULTRASMOOTH AND WARM SENSATIONS LUBRICANT
• Classification: Condom
• Applicant: CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543
• Contact: Stephen C Kolakowsky
• Correspondent: Stephen C Kolakowsky; CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-25
• Decision Date: 2007-11-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00022600001492	K073016	000