WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL


Device Classification Name

tube, tracheal (w/wo connector)

510(k) Number K110269
Device Name WELL LEAD ENDOTRACHEAL TUBE WITH EVACUATION LUMEN-ORAL
Applicant
WELL LEAD MEDICAL CO. LTD
962 allegro lane
apollo beach, 
FL 
33572

Applicant Contact john obrien
Correspondent
WELL LEAD MEDICAL CO. LTD
962 allegro lane
apollo beach, 
FL 
33572

Correspodent Contact john obrien
Regulation Number 868.5730
Classification Product Code
BTR  
Subsequent Product Code
BSY  
Date Received 01/27/2011
Decision Date 08/26/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No