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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K050135
Device Name K-C HEMOSTATIC BIOPSY SYSTEM
Applicant
Bioengineering Consultants , Ltd.
801 W. Main St.
Charlottesville,  VA  22903
Applicant Contact WILLIAM R KRAUSE
Correspondent
Bioengineering Consultants , Ltd.
801 W. Main St.
Charlottesville,  VA  22903
Correspondent Contact WILLIAM R KRAUSE
Regulation Number876.1075
Classification Product Code
FCG  
Date Received01/21/2005
Decision Date 07/13/2005
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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