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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Blood, Cardiopulmonary Bypass, Roller Type
510(k) Number K955038
Device Name STOCKERT S3 DOUBLE HEAD PUMP MODULE
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 Number870.4370
Classification Product Code
DWB  
Date Received11/03/1995
Decision Date 02/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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