FDA 510(k), K170039, STERRAD VELOCITY Biological Indictator and Reader

FDA 510(k), K170039, STERRAD VELOCITY Biological Indictator and Reader

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510(K) Number: K170039
Device Name: STERRAD VELOCITY Biological Indictator and Reader
Manufacturer: Sun Choi
Device Classification Name: Indicator, Biological Sterilization Process
Regulation Number: FRC
Classification Product Code: KXA
Date Received: 01/05/2017
Decision Date: 06/20/2017
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

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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