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510(k) K123732

HYSTEROSCOPY PUMP HM6 by W.O.M. World of Medicine AG — Product Code HIG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2013
Date Received
December 5, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Hysteroscopic
Device Class
Class II
Regulation Number
884.1700
Review Panel
OB
Submission Type

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  • K172040 — Aquilex Fluid Control System AQL-100S (February 5, 2018)
  • K172048 — FluidSmart (September 5, 2017)
  • K133799 — THERMEDX FLUID MANAGMENT SYSTEM (June 20, 2014)
  • K112642 — AQUILEX FLUID CONTROL SYSTEM H112 (February 6, 2012)