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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 K120735
Device Name PATHASSIT LIGHT SEEKER
Applicant
Entellus Medical, Inc.
6705 Wedgwood Court N.
Maple Grove,  MN  55311
Applicant Contact GARRETT P AHLBORG
Correspondent
Entellus Medical, Inc.
6705 Wedgwood Court N.
Maple Grove,  MN  55311
Correspondent Contact GARRETT P AHLBORG
Regulation Number874.4420
Classification Product Code
LRC  
Date Received03/09/2012
Decision Date 04/02/2012
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
Predetermined Change
Control Plan Authorized		 No
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