The following data is part of a premarket notification filed by Carter Products with the FDA for Magnum Plus Latex Condoms With Spermicidal Lub..
| Device ID | K904273 |
| 510k Number | K904273 |
| Device Name: | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. |
| Classification | Condom With Nonoxynol-9 |
| Applicant | CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | Stephen Kolakowsky |
| Correspondent | Stephen Kolakowsky CARTER PRODUCTS HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | LTZ |
| CFR Regulation Number | 884.5310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-17 |
| Decision Date | 1990-10-31 |