The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for 155 Sce(tm) Hemodialyzer.
| Device ID | K945631 |
| 510k Number | K945631 |
| Device Name: | 155 SCE(TM) HEMODIALYZER |
| Classification | Dialyzer, Capillary, Hollow Fiber |
| 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 | FJI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-16 |
| Decision Date | 1995-05-18 |