The following data is part of a premarket notification filed by Goosen Enterprises, Inc. with the FDA for Goosen Urinary Drainage System.
| Device ID | K896579 |
| 510k Number | K896579 |
| Device Name: | GOOSEN URINARY DRAINAGE SYSTEM |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | GOOSEN ENTERPRISES, INC. P.O. BOX 10 Goldenrod, FL 32733 |
| Contact | Carl C Goosen |
| Correspondent | Carl C Goosen GOOSEN ENTERPRISES, INC. P.O. BOX 10 Goldenrod, FL 32733 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-20 |
| Decision Date | 1990-02-15 |