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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 K913932
Device Name PERCUTANEOUS DILATOR WITH SHEATH
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 Received09/03/1991
Decision Date 11/22/1991
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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