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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K042611
Device Name LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
Applicant
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact EARL KNIGHT
Correspondent
Cook, Inc.
750 Daniels Way
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact EARL KNIGHT
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/24/2004
Decision Date 11/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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