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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 K892383
Device Name BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
Applicant
PORGES CORP.
5700 WEST 23RD AVE.
GARY,  IN  46406
Applicant Contact HARRY M KAUFMAN
Correspondent
PORGES CORP.
5700 WEST 23RD AVE.
GARY,  IN  46406
Correspondent Contact HARRY M KAUFMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/06/1989
Decision Date 05/04/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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