The following data is part of a premarket notification filed by Carter Products with the FDA for Trojan-enz Lubri. Condoms (modified Labeling).
| Device ID | K901192 |
| 510k Number | K901192 |
| Device Name: | TROJAN-ENZ LUBRI. 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00022600906674 | K901192 | 000 |
| 00813356000125 | K901192 | 000 |
| 80022600926203 | K901192 | 000 |
| 00022600930501 | K901192 | 000 |
| 80022600937520 | K901192 | 000 |