The following data is part of a premarket notification filed by Goosen Enterprises, Inc. with the FDA for Mensink-goosen Catheter.
| Device ID | K844889 |
| 510k Number | K844889 |
| Device Name: | MENSINK-GOOSEN CATHETER |
| Classification | Catheter, Multiple Lumen |
| Applicant | GOOSEN ENTERPRISES, INC. P.O. BOX 10 Goldenrod, FL 32733 |
| Product Code | GBP |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-17 |
| Decision Date | 1985-03-18 |