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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 K002857
Device Name ELS CANNULA (KIT), MODEL M1210-88,M1510-88
Original Applicant
2035 sunset lake rd.
newark,  DE  19702
Original Contact kathleen johnson
Regulation Number870.4210
Classification Product Code
Date Received09/13/2000
Decision Date 10/05/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls