PATHASSIST LIGHT FIBER


Device Classification Name

instrument, ent manual surgical

510(k) Number K111763
Device Name PATHASSIST LIGHT FIBER
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 06/23/2011
Decision Date 09/15/2011
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