The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Percutaneous Nephrostomy Catheter.
| Device ID | K833008 |
| 510k Number | K833008 |
| Device Name: | PERCUTANEOUS NEPHROSTOMY CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1983-10-19 |