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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 K141916
Device Name PATHASSIST LED LIGHT FIBER
Applicant
Entellus Medical, Inc.
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Applicant Contact GARRETT P AHLBORG
Correspondent
Entellus Medical, Inc.
3600 Holly Lane N., Suite 40
Plymouth,  MN  55447
Correspondent Contact GARRETT P AHLBORG
Regulation Number874.4420
Classification Product Code
LRC  
Date Received07/15/2014
Decision Date 08/07/2014
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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