The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Female Urinary Incontinence Sys.
| Device ID | K843128 |
| 510k Number | K843128 |
| Device Name: | FEMALE URINARY INCONTINENCE SYS |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Contact | De Graad |
| Correspondent | De Graad CHESEBROUGH-POND'S U.S.A. CO. TRUMBULL INDUSTRIAL PARK Trumbull, CT 06611 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-09 |
| Decision Date | 1985-01-02 |