The following data is part of a premarket notification filed by Goosen Enterprises, Inc. with the FDA for Goosen Self-lubricating Catheter.
| Device ID | K923848 |
| 510k Number | K923848 |
| Device Name: | GOOSEN SELF-LUBRICATING CATHETER |
| Classification | Catheter, Straight |
| 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 | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-31 |
| Decision Date | 1994-02-18 |