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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ent manual surgical
510(k) Number K121943
Device Name XPRESS MULTI-SINUS DILATION TOOL
Applicant
Entellus Medical, Inc.
3600 HOLLY LANE NORTH
SUITE 40
PLYMOUTH,  MN  55447
Applicant Contact KAREN E PETERSON
Correspondent
Entellus Medical, Inc.
3600 HOLLY LANE NORTH
SUITE 40
PLYMOUTH,  MN  55447
Correspondent Contact KAREN E PETERSON
Regulation Number874.4420
Classification Product Code
LRC  
Date Received07/03/2012
Decision Date 08/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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