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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K022280
Device Name STOCKERT CORONARY PERFUSION CANNULAE
Applicant
STOCKERT INSTRUMENTE GMBH
20193 GOINS DR.
MORRISON,  CO  80465
Applicant Contact LYNNE LEONARD
Correspondent
STOCKERT INSTRUMENTE GMBH
20193 GOINS DR.
MORRISON,  CO  80465
Correspondent Contact LYNNE LEONARD
Regulation Number870.4210
Classification Product Code
DWF  
Date Received07/15/2002
Decision Date 10/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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