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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 K042290
Device Name VACUUM ASSISTED CORE BIOPSY DEVICE
Applicant
Suros Surgical Systems, Inc.
9502 Angola Court Suite 3
Indianapolis,  IN  46268
Applicant Contact JOSEPH MARK
Correspondent
Suros Surgical Systems, Inc.
9502 Angola Court Suite 3
Indianapolis,  IN  46268
Correspondent Contact JOSEPH MARK
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/24/2004
Decision Date 10/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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