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FDA 510(k) Application Details - K030472
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K030472
Device Name
Instrument, Biopsy
Applicant
ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact
MICHAEL J CRADER
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/12/2003
Decision Date
10/09/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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