FDA 510(k) Application Details - K051361

Device Classification Name Instrument, Biopsy

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510(K) Number K051361
Device Name Instrument, Biopsy
Applicant BOSTON SCIENTIFIC CORP.
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact CHRISTINE M CAMERON
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 05/25/2005
Decision Date 06/16/2005
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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