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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 K010128
Device Name COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE
Applicant
COOK VASCULAR, INC.
P.O. BOX 529
LEECHBURG,  PA  15656
Applicant Contact THOMAS J KARDOS
Correspondent
COOK VASCULAR, INC.
P.O. BOX 529
LEECHBURG,  PA  15656
Correspondent Contact THOMAS J KARDOS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received01/16/2001
Decision Date 04/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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