FDA 510(k), K923442, ABTOX PLAZLYTE PROCESS MONITOR

FDA 510(k), K923442, ABTOX PLAZLYTE PROCESS MONITOR

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510(K) Number: K923442
Device Name: ABTOX PLAZLYTE PROCESS MONITOR
Manufacturer: ABTOX, INC.
Device Classification Name: sterilizer, ethylene-oxide gas
Regulation Number: 880.6860
Classification Product Code: FLF
Date Received: 07/13/1992
Decision Date: 12/22/1994
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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