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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K021137
Device Name SANARUS CENTRICA CORE TISSUE BIOPSY SYSTEM
Applicant
Sanarus Medical, Inc.
5880 W. Las Positas,Suite 52
Pleasanton,  CA  94588
Applicant Contact VICENT CUTARELLI
Correspondent
Sanarus Medical, Inc.
5880 W. Las Positas,Suite 52
Pleasanton,  CA  94588
Correspondent Contact VICENT CUTARELLI
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/09/2002
Decision Date 06/26/2002
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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