The following data is part of a premarket notification filed by Conceivex Inc. with the FDA for Conceivex Latex-free Semen Collector.
| Device ID | K080752 |
| 510k Number | K080752 |
| Device Name: | CONCEIVEX LATEX-FREE SEMEN COLLECTOR |
| Classification | Kit, Conception-assist, Home Use |
| Applicant | CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 -0031 |
| Contact | Blix Winston |
| Correspondent | Blix Winston CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 -0031 |
| Product Code | OBB |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-17 |
| Decision Date | 2008-05-14 |
| Summary: | summary |