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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 K931025
Device Name INTHERM STASIS VALVE SYSTEM
Applicant
INTERVENTIONAL THERAPEUTICS CORP.
2665 MARINE WAY
MOUNTAIN VIEW,  CA  94043
Applicant Contact COLIN J NICHOLS
Correspondent
INTERVENTIONAL THERAPEUTICS CORP.
2665 MARINE WAY
MOUNTAIN VIEW,  CA  94043
Correspondent Contact COLIN J NICHOLS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/01/1993
Decision Date 09/28/1993
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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