The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek Percutaneous Nephrost. Stent.
| Device ID | K821776 |
| 510k Number | K821776 |
| Device Name: | SURGITEK PERCUTANEOUS NEPHROST. STENT |
| 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 | 1982-06-17 |
| Decision Date | 1982-08-10 |