The following data is part of a premarket notification filed by Carter Products with the FDA for Trojan Polyurethane Condom.
| Device ID | K942697 |
| 510k Number | K942697 |
| Device Name: | TROJAN POLYURETHANE CONDOM |
| Classification | Condom, Synthetic |
| Applicant | CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | MOL |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-08 |
| Decision Date | 1995-06-22 |