PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA


Device Classification Name

tube, tracheostomy (w/wo connector)

510(k) Number K030381
Device Name PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE (CUFFED) WITH REUSABLE INNER CANNULA
Applicant
PORTEX LTD.
military road
hythe, kent
england ct21 6db, 

GB

Applicant Contact steve ogilvie
Correspondent
PORTEX LTD.
military road
hythe, kent
england ct21 6db, 

GB

Correspodent Contact steve ogilvie
Regulation Number 868.5800
Classification Product Code
BTO  
Date Received 02/05/2003
Decision Date 08/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No