The following data is part of a premarket notification filed by Conceivex Inc. with the FDA for Conceivex Conception Kit.
| Device ID | K063227 |
| 510k Number | K063227 |
| Device Name: | CONCEIVEX CONCEPTION KIT |
| Classification | Kit, Conception-assist, Home Use |
| Applicant | CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Contact | Blix Winston |
| Correspondent | Blix Winston CONCEIVEX INC. 2600 MULLINIX MILL ROAD Mt. Airy, MD 21771 |
| Product Code | OBB |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-24 |
| Decision Date | 2007-03-14 |
| Summary: | summary |