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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K000715
Device Name ENVOY AND VISTA BRITE TIP
Applicant
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact DENNIS S GRIFFIN
Correspondent
Cordis Corp.
14201 N.W 60th Ave.
Miami Lakes,  FL  33014
Correspondent Contact DENNIS S GRIFFIN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received03/02/2000
Decision Date 03/31/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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