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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K031005
Device Name LUMEND FRONTRUNNER GW CTO 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
PDU  
Subsequent Product Code
DQY  
Date Received03/31/2003
Decision Date 06/18/2003
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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