The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for Ps 15 Polysulfone Hollow Fiber Membrane Hemodialyzer, Model 239-015.
| Device ID | K990643 |
| 510k Number | K990643 |
| Device Name: | PS 15 POLYSULFONE HOLLOW FIBER MEMBRANE HEMODIALYZER, MODEL 239-015 |
| 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 | Amaury Sanchez |
| Correspondent | Amaury Sanchez 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 | 1999-02-26 |
| Decision Date | 1999-12-07 |
| Summary: | summary |