EXTRACORPOREALS' ALTERNATE MEMBRANE

Dialyzer, Capillary, Hollow Fiber

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Extracorporeals' Alternate Membrane.

Pre-market Notification Details

Device IDK801344
510k NumberK801344
Device Name:EXTRACORPOREALS' ALTERNATE MEMBRANE
ClassificationDialyzer, Capillary, Hollow Fiber
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, 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 Received1980-06-05
Decision Date1980-07-21

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