CAPILLARY FLOW DIALYZERS

Accessories, Blood Circuit, Hemodialysis

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Capillary Flow Dialyzers.

Pre-market Notification Details

Device IDK823826
510k NumberK823826
Device Name:CAPILLARY FLOW DIALYZERS
ClassificationAccessories, Blood Circuit, Hemodialysis
Applicant TRAVENOL LABORATORIES, S.A. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOC  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-20
Decision Date1983-01-12

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