The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Trojan Extra Large Latex Condom.
| Device ID | K001212 |
| 510k Number | K001212 |
| Device Name: | TROJAN EXTRA LARGE LATEX CONDOM |
| Classification | Condom |
| Applicant | ARMKEL, LLC. HALF ACRE RD. P.O. BOX 1001 Cranbury, NJ 08512 |
| Contact | Stephen C Kolakowsky |
| Correspondent | Stephen 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-14 |
| Decision Date | 2000-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80022600647146 | K001212 | 000 |