The following data is part of a premarket notification filed by Althin Medical Ab An Affiliate Of Baxter Intl with the FDA for Altra Nova 200 Hemodialyzer.
Device ID | K970681 |
510k Number | K970681 |
Device Name: | ALTRA NOVA 200 HEMODIALYZER |
Classification | Hemodialyzer, Re-use, High Flux |
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 | MSF |
CFR Regulation Number | 876.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-24 |
Decision Date | 1998-07-23 |
Summary: | summary |