SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS

Accessory Equipment, 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 Integrated Cardioplegia Deliv. Sys.

Pre-market Notification Details

Device IDK810079
510k NumberK810079
Device Name:SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
ClassificationAccessory Equipment, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKRI  
CFR Regulation Number870.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-13
Decision Date1981-01-30

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50699753002000 K810079 000
50699753001966 K810079 000
50699753001959 K810079 000
50699753001942 K810079 000
50699753001218 K810079 000

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