WELL LEAD REINFORCED ENDOTRACHEAL TUBE


Device Classification Name

tube, tracheal (w/wo connector)

510(k) Number K073383
Device Name WELL LEAD REINFORCED ENDOTRACHEAL TUBE
Applicant
WELL LEAD MEDICAL INSTRUMENTS
962 allergo lane
apollo beach, 
FL 
33572

Applicant Contact arthur j ward
Correspondent
WELL LEAD MEDICAL INSTRUMENTS
962 allergo lane
apollo beach, 
FL 
33572

Correspodent Contact arthur j ward
Regulation Number 868.5730
Classification Product Code
BTR  
Date Received 12/03/2007
Decision Date 07/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No