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FDA 510(k), K153689, STERIZONE Sterilizer
FDA 510(k), K153689, STERIZONE Sterilizer
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$149.00 USD
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510(K) Number: K153689
Device Name: STERIZONE Sterilizer
Manufacturer: NATHALIE RACETTE
Device Classification Name: Two Or More Sterilant Sterilizer
Regulation Number: PJJ
Classification Product Code: 12/23/2015
Date Received: 06/30/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
Device Name: STERIZONE Sterilizer
Manufacturer: NATHALIE RACETTE
Device Classification Name: Two Or More Sterilant Sterilizer
Regulation Number: PJJ
Classification Product Code: 12/23/2015
Date Received: 06/30/2016
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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