The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Gambro Fiber Hemofilters Fh 22/66 Dispos Tube Sets.
| Device ID | K860938 |
| 510k Number | K860938 |
| Device Name: | GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire, IL 60069 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-12 |
| Decision Date | 1986-04-07 |