SINUS SPACER


Device Classification Name

cannula, sinus

510(k) Number K072891
Device Name SINUS SPACER
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 878.4800
Classification Product Code
KAM  
Date Received 10/10/2007
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No