The following data is part of a premarket notification filed by London Intl. Llc. with the FDA for Durex Lubragel Latex Condom.
| Device ID | K983380 |
| 510k Number | K983380 |
| Device Name: | DUREX LUBRAGEL LATEX CONDOM |
| Classification | Condom |
| Applicant | LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan, AL 36304 |
| Contact | Neil Anderson |
| Correspondent | Neil Anderson LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan, AL 36304 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-25 |
| Decision Date | 1998-11-16 |
| Summary: | summary |