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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 K040592
Device Name CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
Applicant
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact DAVID KORNHAUSER
Correspondent
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact DAVID KORNHAUSER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received03/08/2004
Decision Date 12/17/2004
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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