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510(k) K152278

ENDOFLOW II - Irrigation, Warming and Suction System by Promepla Sam — Product Code OCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 2016
Date Received
August 12, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Irrigation/Suction System
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

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  • K120160 — ROCAMED ROCAUS PLATINUM (May 14, 2012)

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