SARNS INFANT VENOUS RESERVOIR MODEL #16387

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 Sarns Infant Venous Reservoir Model #16387.

Pre-market Notification Details

Device IDK883345
510k NumberK883345
Device Name:SARNS INFANT VENOUS RESERVOIR MODEL #16387
ClassificationReservoir, Blood, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor,  MI  48103
ContactDenise Shimokochi
CorrespondentDenise Shimokochi
3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor,  MI  48103
Product CodeDTN  
CFR Regulation Number870.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-09
Decision Date1988-09-28

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