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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
Applicant
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Applicant Contact RONALD A WILLIAMS
Correspondent
DLP, INC.
620 WATSON S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Correspondent Contact RONALD A WILLIAMS
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/01/1985
Decision Date 04/29/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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