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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 K070410
Device Name COOK MICROWIRE WIRE GUIDE
Applicant
Cook, Inc.
P.O.Box 489
Bloomington,  IN  47402
Applicant Contact KAREN BRADBURN
Correspondent
Cook, Inc.
P.O.Box 489
Bloomington,  IN  47402
Correspondent Contact KAREN BRADBURN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received02/12/2007
Decision Date 04/27/2007
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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