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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 K072302
Device Name ENTELLUS MEDICAL RS-SERIES SYSTEM
Applicant
Entellus Medical, Inc.
10200 73RD. AVE. NORTH
SUTIE 122
MAPLE GROVE,  MN  55369
Applicant Contact TOM RESSEMANN
Correspondent
Entellus Medical, Inc.
10200 73RD. AVE. NORTH
SUTIE 122
MAPLE GROVE,  MN  55369
Correspondent Contact TOM RESSEMANN
Regulation Number874.4420
Classification Product Code
LRC  
Date Received08/17/2007
Decision Date 04/08/2008
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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