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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 K002118
Device Name STOCKERT COMPACT SYSTEM VERSION 2.0
Applicant
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact CYNTHIA J. M. NOLTE
Correspondent
STOECKERT INSTRUMENTE
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact CYNTHIA J. M. NOLTE
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received07/13/2000
Decision Date 08/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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