SARNS NON-FILTERED VENOUS RESERVOIR

Defoamer, Cardiopulmonary Bypass

3M HEALTH CARE, LTD.

The following data is part of a premarket notification filed by 3m Health Care, Ltd. with the FDA for Sarns Non-filtered Venous Reservoir.

Pre-market Notification Details

Device IDK912915
510k NumberK912915
Device Name:SARNS NON-FILTERED VENOUS RESERVOIR
ClassificationDefoamer, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
ContactCathy L Simpson
CorrespondentCathy L Simpson
3M HEALTH CARE, LTD. 6200 JACKSON RD. P.O. BOX 1247 Ann Arbor,  MI  48106
Product CodeDTP  
CFR Regulation Number870.4230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-03
Decision Date1991-09-25

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