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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K821819
Device Name PIGTAIL STENTS
Applicant
AMERICAN ENDOSCOPY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AMERICAN ENDOSCOPY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/21/1982
Decision Date 08/20/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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