MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)


Device Classification Name

tube, tracheal (w/wo connector)

510(k) Number K080339
Device Name MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)
Applicant
MEDSOURCE INTERNATIONAL, LLC.
11715 fox road
suite 400-180
indianapolis, 
IN 
46236

Applicant Contact howard t cooper
Correspondent
MEDSOURCE INTERNATIONAL, LLC.
11715 fox road
suite 400-180
indianapolis, 
IN 
46236

Correspodent Contact howard t cooper
Regulation Number 868.5730
Classification Product Code
BTR  
Date Received 02/08/2008
Decision Date 10/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No