The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Catheter, Radiopaque Tenckhoff.
| Device ID | K782057 |
| 510k Number | K782057 |
| Device Name: | CATHETER, RADIOPAQUE TENCKHOFF |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | DRAVON MEDICAL, INC. 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 | 1978-12-07 |
| Decision Date | 1979-02-27 |