CAPILLARY FLOW DIALYZERS

Dialyzer, Capillary, Hollow Fiber

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 IDK870169
510k NumberK870169
Device Name:CAPILLARY FLOW DIALYZERS
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
ContactRobert L Wilkinson
CorrespondentRobert L Wilkinson
TRAVENOL LABORATORIES, S.A. WILSON RD. AT ROUTE 120 P.O. BOX 490 Round Lake,  IL  60073
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-14
Decision Date1987-04-06

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