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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 K023923
Device Name SENOCOR 360 CIRCUMFERENTIAL VACUUM ASSISTED BIOPSY DEVICE, 8 GAUGE
Applicant
SENORX, INC.
11 COLUMBIA, SUITE A
ALISO VIEJO,  CA  92656
Applicant Contact AMY BOUCLY
Correspondent
SENORX, INC.
11 COLUMBIA, SUITE A
ALISO VIEJO,  CA  92656
Correspondent Contact AMY BOUCLY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received11/25/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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