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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 K080360
Device Name ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER
Applicant
Endologix, Inc.
11 Studebaker
Irvine,  CA  92618
Applicant Contact ANNALIZA VICTORIA
Correspondent
Endologix, Inc.
11 Studebaker
Irvine,  CA  92618
Correspondent Contact ANNALIZA VICTORIA
Regulation Number870.1250
Classification Product Code
DQY  
Date Received02/11/2008
Decision Date 04/08/2008
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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