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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 K110158
Device Name ILLUMINATING SINUS SEEKER
Applicant
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE,  MN  55311
Applicant Contact KAREN E PETERSON
Correspondent
Entellus Medical, Inc.
6705 WEDGWOOD COURT NORTH
MAPLE GROVE,  MN  55311
Correspondent Contact KAREN E PETERSON
Regulation Number874.4420
Classification Product Code
LRC  
Date Received01/19/2011
Decision Date 06/07/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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