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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 K032506
Device Name SANARUS CENTRICA II ROTATIONAL CORE BIOPSY SYSTEM
Applicant
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS BLVD.
SUITE 52
PLEASANTON,  CA  94588
Applicant Contact TRENA DEPEL
Correspondent
SANARUS MEDICAL, INC.
5880 WEST LAS POSITAS BLVD.
SUITE 52
PLEASANTON,  CA  94588
Correspondent Contact TRENA DEPEL
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/14/2003
Decision Date 10/09/2003
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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