RELIEVA SOLO ELITE SINUS BALLOON CATHETER


Device Classification Name

instrument, ent manual surgical

510(k) Number K111254
Device Name RELIEVA SOLO ELITE SINUS BALLOON CATHETER
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Applicant Contact kim ky
Correspondent
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Correspodent Contact kim ky
Regulation Number 874.4420
Classification Product Code
LRC  
Date Received 05/04/2011
Decision Date 08/22/2011
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