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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 (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls