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FDA 510(k) Application Details - K034021
Device Classification Name
Instrument, Biopsy
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510(K) Number
K034021
Device Name
Instrument, Biopsy
Applicant
SUROS SURGICAL SYSTEMS, INC.
9502 ANGOLA COURT SUITE 3
INDIANAPOLIS, IN 46268 US
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Contact
JOSEPH L MARK
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Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
12/24/2003
Decision Date
09/08/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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