VENTILATION TUBES


Device Classification Name

tube, tympanostomy

510(k) Number K960477
Device Name VENTILATION TUBES
Applicant
SMITH & NEPHEW, INC.
555 13th st., n.w.
washington, 
DC 
20004

Applicant Contact howard m holstein
Correspondent
SMITH & NEPHEW, INC.
555 13th st., n.w.
washington, 
DC 
20004

Correspodent Contact howard m holstein
Regulation Number 874.3880
Classification Product Code
ETD  
Date Received 02/01/1996
Decision Date 02/26/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

Type Traditional
Reviewed by Third Party No

Combination Product

No