The following data is part of a premarket notification filed by London Intl. Llc. with the FDA for Durex Ultra Comfort.
| Device ID | K980319 |
| 510k Number | K980319 |
| Device Name: | DUREX ULTRA COMFORT |
| Classification | Condom |
| Applicant | LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 Dothan, AL 36304 |
| Contact | Neil Anderson, Rac |
| Correspondent | Neil Anderson, Rac 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-05-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340912782 | K980319 | 000 |
| 10302340983560 | K980319 | 000 |
| 10302340983553 | K980319 | 000 |
| 10302340301609 | K980319 | 000 |
| 20067981860034 | K980319 | 000 |
| 00023409577201 | K980319 | 000 |
| 40302340957722 | K980319 | 000 |
| 10067981160489 | K980319 | 000 |
| 00067981087192 | K980319 | 000 |
| 10302340876510 | K980319 | 000 |
| 10302340876503 | K980319 | 000 |
| 10302340876459 | K980319 | 000 |
| 10302340876442 | K980319 | 000 |
| 10302340876435 | K980319 | 000 |
| 10302340995518 | K980319 | 000 |
| 10302340995525 | K980319 | 000 |
| 20302340912772 | K980319 | 000 |
| 20302340912765 | K980319 | 000 |
| 10302340853788 | K980319 | 000 |
| 10302340302712 | K980319 | 000 |
| 20302340241001 | K980319 | 000 |
| 20302340129002 | K980319 | 000 |
| 10679810871901 | K980319 | 000 |
| 10679810871802 | K980319 | 000 |
| 10679810871703 | K980319 | 000 |
| 20302340995546 | K980319 | 000 |
| 00067981087185 | K980319 | 000 |
| 00067981087178 | K980319 | 000 |
| 10067981087755 | K980319 | 000 |
| 00302340301602 | K980319 | 000 |