The following data is part of a premarket notification filed by W.r. Grace & Co.-conn. with the FDA for Modified Hollow Fibers Used In Diafilter Hemofil..
| Device ID | K873887 |
| 510k Number | K873887 |
| Device Name: | MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | W.R. GRACE & CO.-CONN. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Contact | James M Delaney |
| Correspondent | James M Delaney W.R. GRACE & CO.-CONN. 17 CHERRY HILL DR. Danvers, MA 01923 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-23 |
| Decision Date | 1987-12-09 |