The following data is part of a premarket notification filed by Sil-med Corp. with the FDA for Tenckhoff Catheter.
| Device ID | K801818 |
| 510k Number | K801818 |
| Device Name: | TENCKHOFF CATHETER |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | SIL-MED CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-31 |
| Decision Date | 1980-10-23 |