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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
Model LP100
Device Name PATHASSIT LIGHT SEEKER
Original Applicant
ENTELLUS MEDICAL, INC.
6705 wedgwood court north
maple grove,  MN  55311
Original Contact garrett p ahlborg
Regulation Number874.4420
Classification Product Code
LRC  
Date Received03/09/2012
Decision Date 04/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ear Nose & Throat
Review Advisory Committee Ear Nose & Throat
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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