FDA 510(k), K153392, STERIZONE VP4 Sterilizer

FDA 510(k), K153392, STERIZONE VP4 Sterilizer

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510(K) Number: K153392
Device Name: STERIZONE VP4 Sterilizer
Manufacturer: TS03 INC
Device Classification Name: two or more sterilant sterilizer
Regulation Number: 880.6860
Classification Product Code: PJJ
Date Received: 11/24/2015
Decision Date: 03/24/2016
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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