The following data is part of a premarket notification filed by Mentor Corp. with the FDA for Female Urine Sampling Device.
| Device ID | K922346 |
| 510k Number | K922346 |
| Device Name: | FEMALE URINE SAMPLING DEVICE |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Contact | Byron H Wickett |
| Correspondent | Byron H Wickett MENTOR CORP. 5425 HOLLISTER AVE. Santa Barbara, CA 93111 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-19 |
| Decision Date | 1992-08-14 |