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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K925742
Device Name CLARUS CHOLANGIOGRAM CATHETER KIT
Applicant
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Applicant Contact GREGORY J MATHISON
Correspondent
Clarus Medical Systems, Inc.
2605 Fernbrook La
Minneapolis,  MN  55447
Correspondent Contact GREGORY J MATHISON
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received11/13/1992
Decision Date 06/01/1993
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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