The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Lundia 10-2-l Parallel Plate Hemodialy.
| Device ID | K832894 |
| 510k Number | K832894 |
| Device Name: | LUNDIA 10-2-L PARALLEL PLATE HEMODIALY |
| Classification | Accessories, Blood Circuit, Hemodialysis |
| Applicant | GAMBRO, INC. 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 | 1983-08-26 |
| Decision Date | 1983-10-14 |