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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 K152435
Device Name PassAssist LED Light Fiber
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 Received08/27/2015
Decision Date 11/20/2015
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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