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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
Applicant
JOSTRA AG
2035 SUNSET LAKE RD.
NEWARK,  DE  19702
Applicant Contact KATHLEEN JOHNSON
Correspondent
JOSTRA AG
2035 SUNSET LAKE RD.
NEWARK,  DE  19702
Correspondent Contact KATHLEEN JOHNSON
Regulation Number870.4210
Classification Product Code
DWF  
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
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