RELIEVA SPIN SINUS DILATION SYSTEM


Device Classification Name

instrument, ent manual surgical

510(k) Number K111875
Device Name RELIEVA SPIN SINUS DILATION SYSTEM
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

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

Correspodent Contact keri yen
Regulation Number 874.4420
Classification Product Code
LRC  
Date Received 07/01/2011
Decision Date 10/11/2011
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