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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 K955110
Device Name NAVARRE PERCUTANEOUS BILIARY DRAINAGE
Applicant
Navarre Biomedical , Ltd.
2545 Fernbrook Ln. N.
Plymouth,  MN  55447
Applicant Contact KELLY BEHRENDT
Correspondent
Navarre Biomedical , Ltd.
2545 Fernbrook Ln. N.
Plymouth,  MN  55447
Correspondent Contact KELLY BEHRENDT
Regulation Number876.5010
Classification Product Code
FGE  
Date Received11/08/1995
Decision Date 11/07/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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