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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 S.W., P.O. BOX 409
GRAND RAPIDS,  MI  49501
Applicant Contact ROGER W BRINK
Correspondent
DLP, INC.
620 WATSON S.W., 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
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