RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET


Device Classification Name

tube tracheostomy and tube cuff

510(k) Number K122235
Device Name RUSCH TRACFLEX PLUS TRACHEOSTOMY TUBE SET
Applicant
Teleflex Medical, Inc.
2917 weck dr.
research triangle park, 
NC 
27709

Applicant Contact lori pfohl
Correspondent
Teleflex Medical, Inc.
2917 weck dr.
research triangle park, 
NC 
27709

Correspodent Contact lori pfohl
Regulation Number 868.5800
Classification Product Code
JOH  
Date Received 07/26/2012
Decision Date 09/06/2013
Decision

substantially equivalent

(SESE)
Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology
summary

summary

Type Special
Reviewed by Third Party No
Combination Product

No