The following data is part of a premarket notification filed by Van-tec, Inc. with the FDA for Percutaneous Nephrostomy Set.
| Device ID | K820867 |
| 510k Number | K820867 |
| Device Name: | PERCUTANEOUS NEPHROSTOMY SET |
| Classification | Catheter, Nephrostomy, General & Plastic Surgery |
| Applicant | VAN-TEC, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBO |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-29 |
| Decision Date | 1982-04-13 |