SARNS 800 ROLLER PUMP

Pump, Blood, Cardiopulmonary Bypass, Roller Type

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Sarns 800 Roller Pump.

Pre-market Notification Details

Device IDK953901
510k NumberK953901
Device Name:SARNS 800 ROLLER PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant 3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
ContactCheryl Rosenberg
CorrespondentCheryl Rosenberg
3M HEALTH CARE, SARNS 6200 JACKSON RD. PO BOX 1247 Ann Arbor,  MI  48106
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-08-18
Decision Date1996-04-19
Summary:summary

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