FDA 510(k), K180342, SYSTEM 1E Liquid Chemical Sterilant Processing System

FDA 510(k), K180342, SYSTEM 1E Liquid Chemical Sterilant Processing System

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510(K) Number: K180342
Device Name: SYSTEM 1E Liquid Chemical Sterilant Processing System
Manufacturer: Jennifer Nalepka
Device Classification Name: Sterilant, Medical Devices
Regulation Number: MED
Classification Product Code: KXA
Date Received: 02/07/2018
Decision Date: 04/04/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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