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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 K014117
Device Name MODIFICATION TO OUTBACK CATHETER
Applicant
LUMEND, INC.
400 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Applicant Contact PHIL HOPPER
Correspondent
LUMEND, INC.
400 CHESAPEAKE DR.
REDWOOD CITY,  CA  94063
Correspondent Contact PHIL HOPPER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/14/2001
Decision Date 01/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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