The following data is part of a premarket notification filed by Ssl Americas with the FDA for Durex Studded/ribbed Lubricated Latex Condom.
| Device ID | K040185 |
| 510k Number | K040185 |
| Device Name: | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM |
| Classification | Condom |
| Applicant | SSL AMERICAS 3585 ENGINEERING DR. Norcross, GA 30092 |
| Contact | Kathleen J Harris |
| Correspondent | Kathleen J Harris SSL AMERICAS 3585 ENGINEERING DR. Norcross, GA 30092 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-27 |
| Decision Date | 2004-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340302736 | K040185 | 000 |
| 20067981160479 | K040185 | 000 |
| 10067981087274 | K040185 | 000 |
| 20067981087769 | K040185 | 000 |
| 10067981087250 | K040185 | 000 |
| 20067981087264 | K040185 | 000 |
| 20679810872509 | K040185 | 000 |
| 20679810872608 | K040185 | 000 |
| 20679810872707 | K040185 | 000 |
| 10302340301784 | K040185 | 000 |
| 10302340301913 | K040185 | 000 |
| 00302340995696 | K040185 | 000 |