EXP 200 PARALLEL PLATE DIALYZER

Dialyzer, Parallel Flow

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Exp 200 Parallel Plate Dialyzer.

Pre-market Notification Details

Device IDK811439
510k NumberK811439
Device Name:EXP 200 PARALLEL PLATE DIALYZER
ClassificationDialyzer, Parallel Flow
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJG  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-22
Decision Date1981-06-12

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