ERIKA HPF 300

Dialyzer, Capillary, Hollow Fiber

ERIKA, INC.

The following data is part of a premarket notification filed by Erika, Inc. with the FDA for Erika Hpf 300.

Pre-market Notification Details

Device IDK791322
510k NumberK791322
Device Name:ERIKA HPF 300
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant ERIKA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-12
Decision Date1979-09-24

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