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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K111747
Device Name ENDOLOGIX AFX INTRODUCER SYSTEM
Applicant
ENDOLOGIX, INC.
11 STUDEBAKER
IRVINE,  CA  92618
Applicant Contact Janet M Fauls
Correspondent
ENDOLOGIX, INC.
11 STUDEBAKER
IRVINE,  CA  92618
Correspondent Contact Janet M Fauls
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/22/2011
Decision Date 07/12/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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