The following data is part of a premarket notification filed by Coloplast A/s with the FDA for Coloplast Uro 2002 Night Drainage System.
| Device ID | K844684 |
| 510k Number | K844684 |
| Device Name: | COLOPLAST URO 2002 NIGHT DRAINAGE SYSTEM |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | COLOPLAST A/S 6206 BENJAMIN RD. Tampa, FL 33614 |
| Contact | Dave Heffner |
| Correspondent | Dave Heffner COLOPLAST A/S 6206 BENJAMIN RD. Tampa, FL 33614 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-30 |
| Decision Date | 1985-01-08 |