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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 K994358
Device Name ATW MARKER WIRE STEERABLE GUIDEWIRE
Applicant
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact DENNIS S GRIFFIN
Correspondent
Cordis Corp.
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact DENNIS S GRIFFIN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/27/1999
Decision Date 01/13/2000
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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