BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES


Device Classification Name

tube tracheostomy and tube cuff

510(k) Number K081440
Device Name BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES
Applicant
SMITHS MEDICAL ASD, INC.
6250 shier rings rd.
dublin, 
OH 
43016

Applicant Contact barbara law
Correspondent
SMITHS MEDICAL ASD, INC.
6250 shier rings rd.
dublin, 
OH 
43016

Correspodent Contact barbara law
Regulation Number 868.5800
Classification Product Code
JOH  
Date Received 05/22/2008
Decision Date 09/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No