FDA 510(k) Application Details - K172288

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

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510(K) Number K172288
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant Wilson-Cook Medical, Inc./ Cook Endoscopy
4900 Bethania Station Road
Winston Salem, NC 27105 US
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Contact Sierra Lowe
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 07/31/2017
Decision Date 04/17/2018
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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