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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 K120962
Original Applicant
Entellus Medical, Inc.
6705 wedgwood court north
maple grove,  MN  55311
Original Contact garrett p ahlborg
Regulation Number874.4420
Classification Product Code
Date Received03/30/2012
Decision Date 04/27/2012
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