BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE


Device Classification Name

tube, tracheostomy (w/wo connector)

510(k) Number K030570
Device Name BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE
Applicant
PORTEX LTD.
military road
hyth, kent, 

GB

ct21 6db

Applicant Contact steve ogilvie
Correspondent
PORTEX LTD.
military road
hyth, kent, 

GB

ct21 6db

Correspodent Contact steve ogilvie
Regulation Number 868.5800
Classification Product Code
BTO  
Date Received 02/24/2003
Decision Date 09/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No