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FDA 510(k) Application Details - K024089
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K024089
Device Name
Instrument, Biopsy
Applicant
BIP USA, INC.
345 THIRD ST., SUITE 400
NIAGARA FALLS, NY 14303 US
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Contact
SIEGFRIED GRUCHOT
Other 510(k) Applications for this Contact
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
12/11/2002
Decision Date
03/11/2003
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
FDA Source Information for K024089
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