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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 K953760
Device Name CORDIS WIZDOM STEERABLE GUIDEWIRE
Applicant
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact KEVIN MACDONALD
Correspondent
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact KEVIN MACDONALD
Regulation Number870.1330
Classification Product Code
DQX  
Date Received08/11/1995
Decision Date 11/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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