THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101

Set, Tubing, Blood, With And Without Anti-regurgitation Valve

EXTRACORPOREAL MEDICAL SPECIALITIES, INC.

The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Therapeutic Exchange Blood Tubing-tp-101.

Pre-market Notification Details

Device IDK831424
510k NumberK831424
Device Name:THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
ClassificationSet, Tubing, Blood, With And Without Anti-regurgitation Valve
Applicant EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFJK  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-05-03
Decision Date1983-10-14

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