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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K023937
Device Name COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM
Applicant
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Applicant Contact THOMAS J KARDOS
Correspondent
Cook Vascular, Inc.
Rt. 66, River Rd.
P.O. Box 529
Leechburg,  PA  15656
Correspondent Contact THOMAS J KARDOS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received11/26/2002
Decision Date 05/27/2003
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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