The following data is part of a premarket notification filed by Pennine Medical Ltd. with the FDA for O'neil Urinary Catheter Introducer.
| Device ID | K854443 |
| 510k Number | K854443 |
| Device Name: | O'NEIL URINARY CATHETER INTRODUCER |
| Classification | Catheter, Urological |
| Applicant | PENNINE MEDICAL LTD. P.O. BOX 648 Stoughton, MA 02072 |
| Contact | David S Locke |
| Correspondent | David S Locke PENNINE MEDICAL LTD. P.O. BOX 648 Stoughton, MA 02072 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-05 |
| Decision Date | 1986-01-08 |