FDA 510(k) Application Details - K133736

Device Classification Name Endoscopic Grasping/Cutting Instrument, Non-Powered

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510(K) Number K133736
Device Name Endoscopic Grasping/Cutting Instrument, Non-Powered
Applicant UNITED STATES ENDOSCOPY GROUP, INC.
5976 HEISLEY RD.
MENTOR, OH 44060 US
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Contact ERIC MAYNARD
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Regulation Number 876.1500

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Classification Product Code OCZ
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Date Received 12/09/2013
Decision Date 01/07/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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