The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Lundia 10 3n Parallel Flow Dial.
| Device ID | K820769 |
| 510k Number | K820769 |
| Device Name: | GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL |
| Classification | System, Dialysate Delivery, Central Multiple Patient |
| Applicant | GAMBRO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FKQ |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-22 |
| Decision Date | 1982-04-16 |