FDA 510(k) Application Details - K000397

Device Classification Name Ligator, Hemorrhoidal

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510(K) Number K000397
Device Name Ligator, Hemorrhoidal
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact ABBY LIPMAN
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Regulation Number 876.4400

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Classification Product Code FHN
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Date Received 02/07/2000
Decision Date 03/07/2000
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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