SARNS TEMPERATURE PROBE AND CONNECTOR

Tubing, Pump, 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 Temperature Probe And Connector.

Pre-market Notification Details

Device IDK905686
510k NumberK905686
Device Name:SARNS TEMPERATURE PROBE AND CONNECTOR
ClassificationTubing, Pump, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactJames Balun
CorrespondentJames Balun
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDWE  
CFR Regulation Number870.4390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-19
Decision Date1991-02-25

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