FDA 510(k) Application Details - K200745

Device Classification Name Snare, Flexible

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510(K) Number K200745
Device Name Snare, Flexible
Applicant United States Endoscopy Group, Inc.
5976 Heisley Road
Mentor, OH 44060 US
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Contact Carroll Martin
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Regulation Number 876.4300

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Classification Product Code FDI
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Date Received 03/23/2020
Decision Date 04/21/2020
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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