The following data is part of a premarket notification filed by Intimate Bridge 2 Conception, Inc with the FDA for Focus Touch Conception System.
| Device ID | K112200 |
| 510k Number | K112200 |
| Device Name: | FOCUS TOUCH CONCEPTION SYSTEM |
| Classification | Kit, Conception-assist, Home Use |
| Applicant | INTIMATE BRIDGE 2 CONCEPTION, INC 3919 WILLIAM PENN HIGHWAY SUITE 200 Murrysville, PA 15668 |
| Contact | Niki C Spaniel |
| Correspondent | Niki C Spaniel INTIMATE BRIDGE 2 CONCEPTION, INC 3919 WILLIAM PENN HIGHWAY SUITE 200 Murrysville, PA 15668 |
| Product Code | OBB |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2012-09-06 |
| Summary: | summary |