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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 K924451
Device Name INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
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 Received09/01/1992
Decision Date 10/23/1992
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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