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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 K980191
Device Name MANAN BILIARY DRAINAGE CATHETER
Applicant
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Applicant Contact KARL SWARTZ
Correspondent
Medical Device Technologies, Inc.
4445 SW 35th Terrace
Suite 310
Gainsville,  FL  32608
Correspondent Contact KARL SWARTZ
Regulation Number876.5010
Classification Product Code
FGE  
Date Received01/20/1998
Decision Date 02/09/1998
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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