CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)

Hemodialyzer, Re-use, High Flux

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Cahp High Performance Cellulose Diacetate (capillary, Hollow Fiber).

Pre-market Notification Details

Device IDK970653
510k NumberK970653
Device Name:CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
ClassificationHemodialyzer, Re-use, High Flux
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactRobert L Wilkinson
CorrespondentRobert L Wilkinson
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
Product CodeMSF  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-02-21
Decision Date1998-03-11
Summary:summary

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