The following data is part of a premarket notification filed by Cook Ob/gyn with the FDA for Female Continence Device.
| Device ID | K883721 |
| 510k Number | K883721 |
| Device Name: | FEMALE CONTINENCE DEVICE |
| Classification | Pessary, Vaginal |
| Applicant | COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Contact | Dexter J Elkins |
| Correspondent | Dexter J Elkins COOK OB/GYN 1100 WEST MORGAN ST. P.O. BOX 271 Spencer, IN 47460 |
| Product Code | HHW |
| CFR Regulation Number | 884.3575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-31 |
| Decision Date | 1988-10-03 |