PARALLEL PLATE DIALYZER HOLDER

Set, Dialyzer Holder

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

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

Pre-market Notification Details

Device IDK811292
510k NumberK811292
Device Name:PARALLEL PLATE DIALYZER HOLDER
ClassificationSet, Dialyzer Holder
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFKI  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-05-11
Decision Date1981-06-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.