RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)


Device Classification Name

cannula, sinus

510(k) Number K110687
Device Name RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

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

Correspodent Contact dean knight
Regulation Number 878.4800
Classification Product Code
KAM  
Date Received 03/11/2011
Decision Date 10/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Ear Nose & Throat

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No