FDA 510(k) Application Details - K002802

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K002802
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact CAROL J HOLLOWAY
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 09/08/2000
Decision Date 10/05/2000
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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