The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Trojan Mint Tingle Brand Latex Condoms.
| Device ID | K023405 |
| 510k Number | K023405 |
| Device Name: | TROJAN MINT TINGLE BRAND LATEX CONDOMS |
| Classification | Condom |
| Applicant | ARMKEL, LLC. 469 NORTH HARRISON ST. Princeton, NJ 08540 -3510 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen C Kolakowsky ARMKEL, LLC. 469 NORTH HARRISON ST. Princeton, NJ 08540 -3510 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-10 |
| Decision Date | 2002-12-16 |
| Summary: | summary |