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.
| Device ID | K050828 |
| 510k Number | K050828 |
| Device Name: | TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM |
| Classification | Condom, Synthetic |
| 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 | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2006-02-28 |
| Summary: | summary |