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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 K973114
Device Name SILICONE BILIARY STENT/BILIARY CATHETER
Applicant
Specialty Surgical Products, Inc.
302 N. First St.
Hamilton,  MT  59840
Applicant Contact T. JAN VARNER
Correspondent
Specialty Surgical Products, Inc.
302 N. First St.
Hamilton,  MT  59840
Correspondent Contact T. JAN VARNER
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/20/1997
Decision Date 09/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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