SARNS 9000 HEART-LUNG CONSOLE

Console, Heart-lung Machine, Cardiopulmonary Bypass

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 9000 Heart-lung Console.

Pre-market Notification Details

Device IDK871131
510k NumberK871131
Device Name:SARNS 9000 HEART-LUNG CONSOLE
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactJoseph W O'donnell
CorrespondentJoseph W O'donnell
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDTQ  
CFR Regulation Number870.4220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-03-20
Decision Date1987-05-21

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