FDA 510(k), K173634, CELERITY 20 Steam Biological Indicator

FDA 510(k), K173634, CELERITY 20 Steam Biological Indicator

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510(K) Number: K173634
Device Name: CELERITY 20 Steam Biological Indicator
Manufacturer: Anthony Piotrkowski
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: KXA
Date Received: 11/24/2017
Decision Date: 02/12/2018
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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