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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube, tracheal/bronchial, differential ventilation (w/wo connector)
510(k) Number K002288
Device Name ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER
Applicant
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
COOK, INC.
925 SOUTH CURRY PIKE
P.O. BOX 489
BLOOMINGTON,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number868.5740
Classification Product Code
CBI  
Date Received07/27/2000
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
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