ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER


definition

Device Classification Name

tube, tracheal/bronchial, differential ventilation (w/wo connector)

510(k) Number K002288
Device Name ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
Original Applicant
COOK, INC.
925 south curry pike
p.o. box 489
bloomington, 
IN 
47402

Original Contact april lavender
Regulation Number 868.5740
Classification Product Code
CBI  
Date Received 07/27/2000
Decision Date 11/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

Type Traditional
Reviewed by Third Party No

Combination Product

No