SARNS PORTABLE POWER MODULE

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 Portable Power Module.

Pre-market Notification Details

Device IDK861388
510k NumberK861388
Device Name:SARNS PORTABLE POWER MODULE
ClassificationConsole, Heart-lung Machine, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactMarshall Smith
CorrespondentMarshall Smith
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 Received1986-04-14
Decision Date1986-06-23

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