SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)

Controller, Temperature, 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 Temp. Control And Monitor System (tcm Ii).

Pre-market Notification Details

Device IDK883603
510k NumberK883603
Device Name:SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)
ClassificationController, Temperature, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor,  MI  48103
ContactD Shimokochi
CorrespondentD Shimokochi
3M HEALTH CARE, SARNS 6200 JACKSON RD. Ann Arbor,  MI  48103
Product CodeDWC  
CFR Regulation Number870.4250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-23
Decision Date1988-11-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00886799001769 K883603 000
00886799001752 K883603 000
00886799001745 K883603 000
00886799000168 K883603 000
00886799000151 K883603 000
00886799000014 K883603 000

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