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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 K121943
Model MSB
Device Name XPRESS MULTI-SINUS DILATION TOOL
Applicant
ENTELLUS MEDICAL, INC.
3600 holly lane north
suite 40
plymouth,  MN  55447
Contact karen e peterson
Regulation Number874.4420
Classification Product Code
LRC  
Date Received07/03/2012
Decision Date 08/22/2012
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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