The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Chesebrough-pond's Uri-drain Male Urinary Pouch.
| Device ID | K845010 |
| 510k Number | K845010 |
| Device Name: | CHESEBROUGH-POND'S URI-DRAIN MALE URINARY POUCH |
| Classification | Garment, Protective, For Incontinence |
| 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 | EYQ |
| CFR Regulation Number | 876.5920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-26 |
| Decision Date | 1985-01-15 |