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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 K953945
Device Name RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH ELONGATED & TREADED CUFF & INTRODUCER STYLET
Applicant
Dlp, Inc.
620 Watson SW
P.O. Box 409
Grand Rapids,  MI  49501
Applicant Contact ROGER W BRINK
Correspondent
Dlp, Inc.
620 Watson SW
P.O. Box 409
Grand Rapids,  MI  49501
Correspondent Contact ROGER W BRINK
Regulation Number870.4210
Classification Product Code
DWF  
Date Received08/21/1995
Decision Date 03/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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