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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 K013284
Device Name LUMEND FRONTRUNNER CTO CORONARY CATHETER
Applicant
Lumend, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Applicant Contact MICHAEL A DANIEL
Correspondent
Lumend, Inc.
400 Chesapeake Dr.
Redwood City,  CA  94063
Correspondent Contact MICHAEL A DANIEL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received10/02/2001
Decision Date 02/11/2002
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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