The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Lundia 10-2-n Parallel Flow Dialyzer.
| Device ID | K830905 |
| 510k Number | K830905 |
| Device Name: | LUNDIA 10-2-N PARALLEL FLOW DIALYZER |
| 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 | 1983-03-21 |
| Decision Date | 1983-04-06 |