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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 K080171
Device Name SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
Applicant
SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON,  CA  94588
Applicant Contact LISA HENRY
Correspondent
SANARUS MEDICAL, INC.
4696 WILLOW RD.
PLEASANTON,  CA  94588
Correspondent Contact LISA HENRY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received01/24/2008
Decision Date 03/06/2008
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
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