The following data is part of a premarket notification filed by Personal Products Co. with the FDA for Ortho Control Female Urinary Control Device.
| Device ID | K010365 |
| 510k Number | K010365 |
| Device Name: | ORTHO CONTROL FEMALE URINARY CONTROL DEVICE |
| Classification | External Urethral Occluder, Urinary Incontinence-control, Female |
| Applicant | PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Contact | Marylou Panico |
| Correspondent | Marylou Panico PERSONAL PRODUCTS CO. 199 GRANDVIEW RD. Skillman, NJ 08558 |
| Product Code | MNG |
| CFR Regulation Number | 876.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-07 |
| Decision Date | 2001-04-30 |