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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Control, Pump Speed, Cardiopulmonary Bypass
510(k) Number K032213
Device Name STOCKERT CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
Applicant
Stockert Instrumente GmbH
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA J.M. NOLTE
Correspondent
Stockert Instrumente GmbH
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA J.M. NOLTE
Regulation Number870.4380
Classification Product Code
DWA  
Date Received07/21/2003
Decision Date 08/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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