TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM

Condom, Synthetic

CHURCH & DWIGHT CO., INC.

The following data is part of a premarket notification filed by Church & Dwight Co., Inc. with the FDA for Trojan Supra Lubricated Polyurethane Male Condom.

Pre-market Notification Details

• Device ID: K100767
• 510k Number: K100767
• Device Name: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
• Classification: Condom, Synthetic
• Applicant: CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543
• Contact: Joseph Ciccone
• Correspondent: Joseph Ciccone; CHURCH & DWIGHT CO., INC. 469 NORTH HARRISON STREET Princeton, NJ 08543
• Product Code: MOL
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-03-18
• Decision Date: 2011-04-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00022600902423	K100767	000
00022600902201	K100767	000