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FDA 510(k), K173629, CELERITY 20 Steam Process Challenge Device for Gravity Cycles
FDA 510(k), K173629, CELERITY 20 Steam Process Challenge Device for Gravity Cycles
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510(K) Number: K173629
Device Name: CELERITY 20 Steam Process Challenge Device for Gravity Cycles
Manufacturer: Anthony Piotrkowski
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: 11/24/2017
Date Received: 02/21/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: CELERITY 20 Steam Process Challenge Device for Gravity Cycles
Manufacturer: Anthony Piotrkowski
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: 11/24/2017
Date Received: 02/21/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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