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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 K110090
Device Name 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 Received01/12/2011
Decision Date 05/26/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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