The following data is part of a premarket notification filed by Hemodialysis, Division Of The with the FDA for Dlc 500, Double Lumen Catheter.
| Device ID | K781050 |
| 510k Number | K781050 |
| Device Name: | DLC 500, DOUBLE LUMEN CATHETER |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | HEMODIALYSIS, DIVISION OF THE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOC |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-06-21 |
| Decision Date | 1978-09-26 |