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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K853586
Device Name PRESSURE SENSING SYRINGE 65000
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 Number870.4290
Classification Product Code
DTL  
Date Received08/26/1985
Decision Date 11/14/1985
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
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