The following data is part of a premarket notification filed by Carter Products with the FDA for Trojan-enz Latex Condoms (modified Labeling).
| Device ID | K901191 |
| 510k Number | K901191 |
| Device Name: | TROJAN-ENZ LATEX CONDOMS (MODIFIED LABELING) |
| Classification | Condom |
| Applicant | CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | C Kolakowsky |
| Correspondent | C Kolakowsky CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-12 |
| Decision Date | 1990-04-16 |