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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 K834468
Device Name DRAINAGE STENT
Applicant
Microvasive
31 Maple St.
Milford,  MA  01757
Applicant Contact unknown unknown
Correspondent
Microvasive
31 Maple St.
Milford,  MA  01757
Correspondent Contact unknown unknown
Regulation Number876.5010
Classification Product Code
FGE  
Subsequent Product Code
FAD  
Date Received12/20/1983
Decision Date 04/20/1984
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
Recalls CDRH Recalls
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