K-SOL(TM)

System, Perfusion, Kidney

ALCON LABORATORIES

The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for K-sol(tm).

Pre-market Notification Details

Device IDK911587
510k NumberK911587
Device Name:K-SOL(TM)
ClassificationSystem, Perfusion, Kidney
Applicant ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
ContactDenise E Mceachern
CorrespondentDenise E Mceachern
ALCON LABORATORIES 6201 SOUTH FREEWAY R7-14 Fort Worth,  TX  76134 -2099
Product CodeKDN  
CFR Regulation Number876.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-09
Decision Date1991-11-01

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