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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 K880421
Device Name DESCENDING ARCH CANNULA
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact VAN HOF
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact VAN HOF
Regulation Number870.4210
Classification Product Code
DWF  
Date Received02/01/1988
Decision Date 04/28/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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