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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 K093512
Device Name ENCOR BREAST BIOPSY SYSTEM
Applicant
Senorx, Inc.
#3 Morgan
Irvine,  CA  92618
Applicant Contact EBEN GORDON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/13/2009
Decision Date 11/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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