The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Trojan Latex Condom With Male Genital Desensitizer Lubricant.
| Device ID | K000748 |
| 510k Number | K000748 |
| Device Name: | TROJAN LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
| Classification | Condom |
| Applicant | ARMKEL, LLC. P.O. BOX 1001, HALF ACRE RD. Cranbury, NJ 08512 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky ARMKEL, LLC. P.O. BOX 1001, HALF ACRE RD. Cranbury, NJ 08512 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-08 |
| Decision Date | 2000-04-06 |