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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 K091681
Device Name FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT)
Applicant
Entellus Medical, Inc.
6705 Wedgwood Court N.
Maple Grove,  MN  55311
Applicant Contact DEBORAH I NEYMARK
Correspondent
Entellus Medical, Inc.
6705 Wedgwood Court N.
Maple Grove,  MN  55311
Correspondent Contact DEBORAH I NEYMARK
Regulation Number874.4420
Classification Product Code
LRC  
Date Received06/10/2009
Decision Date 07/08/2009
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
Predetermined Change
Control Plan Authorized		 No
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