S3 MAST PUMP

Pump, Blood, Cardiopulmonary Bypass, Roller Type

STOECKERT INSTRUMENTE

The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for S3 Mast Pump.

Pre-market Notification Details

Device IDK972321
510k NumberK972321
Device Name:S3 MAST PUMP
ClassificationPump, Blood, Cardiopulmonary Bypass, Roller Type
Applicant STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
ContactRosina Robinson
CorrespondentRosina Robinson
STOECKERT INSTRUMENTE 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeDWB  
CFR Regulation Number870.4370 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-23
Decision Date1998-02-27
Summary:summary

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