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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 SW
Grand Rapids,  MI  49501
Applicant Contact RONALD A WILLIAMS
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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