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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 K865079
Device Name ASPIRATING NEEDLE, CATALOG CODE #12006
Applicant
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Applicant Contact WILLIAMS, PHD
Correspondent
Dlp, Inc.
P.O.Box 409
620 Watsons SW
Grand Rapids,  MI  49501
Correspondent Contact WILLIAMS, PHD
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/29/1986
Decision Date 03/03/1987
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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