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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 K050777
Device Name PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
Applicant
Conmedcorp
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact MICHAEL A PATZ
Correspondent
Conmedcorp
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Correspondent Contact MICHAEL A PATZ
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/28/2005
Decision Date 04/22/2005
Decision Substantially Equivalent (SESE)
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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