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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 K001577
Device Name 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 Received05/22/2000
Decision Date 01/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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