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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, tracheal, expandable
510(k) Number K891411
Device Name GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT
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 Number878.3720
Classification Product Code
JCT  
Date Received03/14/1989
Decision Date 12/18/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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