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 | K171639 |
| 510k Number | K171639 |
| Device Name: | Trojan Supra Lubricated Polyurethane Male Condom |
| Classification | Condom, Synthetic |
| Applicant | Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Contact | Lisa Burns |
| Correspondent | Lisa Burns Church & Dwight Co., Inc. 500 Charles Ewing Blvd. Ewing, NJ 08628 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-02 |
| Decision Date | 2017-08-01 |
| Summary: | summary |