FDA 510(k) Application Details - K110887

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

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510(K) Number K110887
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant Boston Scientific Corporation
100 BOSTON SCIENTIFIC WAY
MARLBOROUGH, MA 01752 US
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Contact ASHLEY PYLE
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 03/30/2011
Decision Date 04/14/2011
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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