XPRESS MULTI-SINUS DILATION TOOL


Device Classification Name

instrument, ent manual surgical

510(k) Number K112506
Device Name XPRESS MULTI-SINUS DILATION TOOL
Applicant
Entellus Medical, Inc.
6705 wedgwood court north
maple grove, 
MN 
55311

Applicant Contact karen e peterson
Correspondent
Entellus Medical, Inc.
6705 wedgwood court north
maple grove, 
MN 
55311

Correspodent Contact karen e peterson
Regulation Number 874.4420
Classification Product Code
LRC  
Date Received 08/30/2011
Decision Date 12/21/2011
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