The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for Altrex(r) 200 Hemodialyzer.
| Device ID | K945595 |
| 510k Number | K945595 |
| Device Name: | ALTREX(R) 200 HEMODIALYZER |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 -9308 |
| Contact | Mary Lane |
| Correspondent | Mary Lane ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes, FL 33014 -9308 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-03-08 |