ALTRA NOVA 200 HEMODIALYZER

Hemodialyzer, Re-use, High Flux

ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL

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.

Pre-market Notification Details

Device IDK970681
510k NumberK970681
Device Name:ALTRA NOVA 200 HEMODIALYZER
ClassificationHemodialyzer, Re-use, High Flux
Applicant ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes,  FL  33014 -9308
ContactAmaury Sanchez
CorrespondentAmaury Sanchez
ALTHIN MEDICAL AB AN AFFILIATE OF BAXTER INTL 14620 N.W. 60TH AVE. Miami Lakes,  FL  33014 -9308
Product CodeMSF  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-24
Decision Date1998-07-23
Summary:summary

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