MODIFIED CARDIOTOMY RESERVOIR 5M1470

Reservoir, Blood, 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 Modified Cardiotomy Reservoir 5m1470.

Pre-market Notification Details

Device IDK862357
510k NumberK862357
Device Name:MODIFIED CARDIOTOMY RESERVOIR 5M1470
ClassificationReservoir, Blood, 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 CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-06-23
Decision Date1986-08-19

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