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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 K011088
Device Name SIII ALARM AMPLIFIER
Applicant
STOCKERT INSTRUMENTE GMBH
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact ROSINA ROBINSON
Correspondent
STOCKERT INSTRUMENTE GMBH
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact ROSINA ROBINSON
Regulation Number870.4220
Classification Product Code
DTQ  
Date Received04/10/2001
Decision Date 05/02/2001
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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