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FDA 510(k), K141580, STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
FDA 510(k), K141580, STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
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510(K) Number: K141580
Device Name: STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
Manufacturer: TSO3 INC.
Device Classification Name: indicator, biological sterilization process
Regulation Number: 880.2800
Classification Product Code: FRC
Date Received: 06/13/2014
Decision Date: 12/17/2014
Regulation Medical Specialty: General Hospital
Device Name: STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR
Manufacturer: TSO3 INC.
Device Classification Name: indicator, biological sterilization process
Regulation Number: 880.2800
Classification Product Code: FRC
Date Received: 06/13/2014
Decision Date: 12/17/2014
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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