FDA 510(k) Application Details - K181418

Device Classification Name Endoscopic Irrigation/Suction System

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510(K) Number K181418
Device Name Endoscopic Irrigation/Suction System
Applicant Partnership Medical Limited
Hartley House, Galveston Grove
Fenton ST43PE GB
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Contact Rob Hartley
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Regulation Number 876.1500

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Classification Product Code OCX
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Date Received 05/31/2018
Decision Date 07/11/2019
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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