FDA 510(k) Application Details - K042753

Device Classification Name Instrument, Biopsy

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510(K) Number K042753
Device Name Instrument, Biopsy
Applicant ETHICON ENDO-SURGERY, INC.
4545 CREEK RD.
CINCINNATI, OH 45242-2839 US
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Contact CAROL J SPRINKLE
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 10/04/2004
Decision Date 11/08/2004
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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