The following data is part of a premarket notification filed by Ssl Americas, Inc. with the FDA for Durex Latex Condom With Male Genital Desensitizer Lubricant.
| Device ID | K020659 |
| 510k Number | K020659 |
| Device Name: | DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT |
| Classification | Condom |
| Applicant | SSL AMERICAS, INC. 3585 ENGINEERING DR.; STE 200 P.O. BOX 926090 Norcross, GA 30092 -9214 |
| Contact | Joyce Ning |
| Correspondent | Joyce Ning SSL AMERICAS, INC. 3585 ENGINEERING DR.; STE 200 P.O. BOX 926090 Norcross, GA 30092 -9214 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-01 |
| Decision Date | 2002-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10302340853290 | K020659 | 000 |
| 40302340853277 | K020659 | 000 |
| 00302340853286 | K020659 | 000 |
| 00302340971386 | K020659 | 000 |
| 00302340989336 | K020659 | 000 |
| 77302340989338 | K020659 | 000 |
| 10302340989333 | K020659 | 000 |
| 40302340856810 | K020659 | 000 |
| 10302340958834 | K020659 | 000 |
| 00023409893363 | K020659 | 000 |
| 00023408568101 | K020659 | 000 |
| 20302340971380 | K020659 | 000 |
| 10302340983546 | K020659 | 000 |
| 20302340300425 | K020659 | 000 |
| 20302340302191 | K020659 | 000 |
| 10302340302743 | K020659 | 000 |
| 20302340853273 | K020659 | 000 |
| 20302340853280 | K020659 | 000 |
| 00302340300421 | K020659 | 000 |