The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gf-180-l Hollow Fiber Hemodialysis.
| Device ID | K831606 |
| 510k Number | K831606 |
| Device Name: | GF-180-L HOLLOW FIBER HEMODIALYSIS |
| 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 | 1983-05-18 |
| Decision Date | 1983-06-24 |