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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gauge, pressure, coronary, cardiopulmonary bypass
510(k) Number K852232
Device Name PRESSURE DISPLAY BOX #60000/TUBING SET #61000
Applicant
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Applicant Contact RONALD A WILLIAMS
Correspondent
DLP, INC.
P.O.BOX 409
620 WATSONS S.W.
GRAND RAPIDS,  MI  49501
Correspondent Contact RONALD A WILLIAMS
Regulation Number870.4310
Classification Product Code
DXS  
Date Received05/22/1985
Decision Date 08/09/1985
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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