The following data is part of a premarket notification filed by Unidus Corp. with the FDA for Unidus Magnum Male Latex Condom.
| Device ID | K072747 |
| 510k Number | K072747 |
| Device Name: | UNIDUS MAGNUM MALE LATEX CONDOM |
| Classification | Condom |
| Applicant | UNIDUS CORP. 507 SHALLOW CREEK ROAD Tuscaloosa, AL 35406 |
| Contact | Claude L Wright |
| Correspondent | Claude L Wright UNIDUS CORP. 507 SHALLOW CREEK ROAD Tuscaloosa, AL 35406 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-27 |
| Decision Date | 2007-11-15 |
| Summary: | summary |