FDA 510(k) Application Details - K024089

Device Classification Name Instrument, Biopsy

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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
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Regulation Number 876.1075

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Classification Product Code KNW
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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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