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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 K850385
Device Name INTRACARDIAC SUMP 12010
Original Applicant
DLP, INC.
620 watson s.w., p.o. box 409
grand rapids,  MI  49501
Original Contact ronald a williams
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/01/1985
Decision Date 04/29/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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