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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name console, heart-lung machine, cardiopulmonary bypass
510(k) Number K950990
Device Name STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE
Applicant
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact DIANE MINEAR
Correspondent
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact DIANE MINEAR
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received03/03/1995
Decision Date 01/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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