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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 K042136
Device Name SANARUS CASSI ROTATIONAL CORE BIOPSY SYSTEM
Applicant
Sanarus Medical, Inc.
5880 W. Las Positas,Suite 52
Pleasanton,  CA  94588
Applicant Contact TRENA DEPEL
Correspondent
Sanarus Medical, Inc.
5880 W. Las Positas,Suite 52
Pleasanton,  CA  94588
Correspondent Contact TRENA DEPEL
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/09/2004
Decision Date 09/08/2004
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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