FDA 510(k) Application Details - K130623

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

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510(K) Number K130623
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant Covidien LLC
15 HAMPSHIRE ST
MANSFIELD, MA 02048 US
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Contact RICHELLE HOVER
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 03/08/2013
Decision Date 07/26/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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