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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 K041032
Device Name MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
Applicant
Orbus Medical Technologies
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309 -6315
Applicant Contact DAVID L CAMP
Correspondent
Orbus Medical Technologies
5363 NW 35th Ave.
Fort Lauderdale,  FL  33309 -6315
Correspondent Contact DAVID L CAMP
Regulation Number876.5010
Classification Product Code
FGE  
Date Received04/21/2004
Decision Date 05/10/2004
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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