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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 K051581
Device Name SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
Applicant
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Applicant Contact TRENA DEPEL
Correspondent
Sanarus Medical, Inc.
4696 Willow Rd.
Pleasanton,  CA  94588
Correspondent Contact TRENA DEPEL
Regulation Number876.1075
Classification Product Code
KNW  
Date Received06/15/2005
Decision Date 07/27/2005
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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