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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Esophageal
510(k) Number K914029
Device Name ESOPHAGEAL Z-STENT
Applicant
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Applicant Contact APRIL LAVENDER
Correspondent
Cook, Inc.
925 S. Curry Pike
P.O. Box 489
Bloomington,  IN  47402
Correspondent Contact APRIL LAVENDER
Regulation Number878.3610
Classification Product Code
ESW  
Date Received09/10/1991
Decision Date 12/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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