HEMOPERFUSION SYSTEM TP-400

Apparatus, Hemoperfusion, Sorbent

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Hemoperfusion System Tp-400.

Pre-market Notification Details

Device IDK831029
510k NumberK831029
Device Name:HEMOPERFUSION SYSTEM TP-400
ClassificationApparatus, Hemoperfusion, Sorbent
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFLD  
CFR Regulation Number876.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-30
Decision Date1983-08-26

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