The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Trojan(r) Extra Str Latex Condom W/sperm Sili Lubr.
| Device ID | K904000 |
| 510k Number | K904000 |
| Device Name: | TROJAN(R) EXTRA STR LATEX CONDOM W/SPERM SILI LUBR |
| Classification | Condom |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | C Kolakowsky |
| Correspondent | C Kolakowsky ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 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 | 1990-08-29 |
| Decision Date | 1991-02-19 |