FDA 510(k) Application Details - K040893

Device Classification Name Kit, Needle, Biopsy

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510(K) Number K040893
Device Name Kit, Needle, Biopsy
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact CHRISTINE M CAMERON
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Regulation Number 876.1075

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Classification Product Code FCG
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Date Received 04/06/2004
Decision Date 05/06/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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