The following data is part of a premarket notification filed by Unidus Corp. with the FDA for Unidus Male Latex Condom (yellow, Pink, Green & Black).
| Device ID | K023129 |
| 510k Number | K023129 |
| Device Name: | UNIDUS MALE LATEX CONDOM (YELLOW, PINK, GREEN & BLACK) |
| Classification | Condom |
| Applicant | UNIDUS CORP. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Contact | Eli J Carter |
| Correspondent | Eli J Carter UNIDUS CORP. 1219 LITTLE CREEK RD. Durham, NC 27713 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-12-13 |
| Summary: | summary |