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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 K897022
Device Name PICSO CANNULA, CATALOG CODE 94315
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact CHET VANHOF
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact CHET VANHOF
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/19/1989
Decision Date 03/16/1990
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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