The following data is part of a premarket notification filed by Navarre Biomedical Ltd. with the FDA for Navarre Percutaneous Access Set.
| Device ID | K942315 |
| 510k Number | K942315 |
| Device Name: | NAVARRE PERCUTANEOUS ACCESS SET |
| Classification | Accessories, Catheter |
| Applicant | NAVARRE BIOMEDICAL LTD. 705 TOWER DR. Hamel, MN 55340 |
| Contact | Gregg S Sutton |
| Correspondent | Gregg S Sutton NAVARRE BIOMEDICAL LTD. 705 TOWER DR. Hamel, MN 55340 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-13 |
| Decision Date | 1994-07-08 |