ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM


Device Classification Name

tube, tympanostomy

510(k) Number K103595
Device Name ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
Applicant
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Applicant Contact gurvinder singh nanda
Correspondent
ACCLARENT, INC.
1525-b o’brien dr.
menlo park, 
CA 
94025

Correspodent Contact gurvinder singh nanda
Regulation Number 874.3880
Classification Product Code
ETD  
Date Received 12/08/2010
Decision Date 04/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Clinical Trials NCT01202578
Reviewed by Third Party No

Combination Product

No