FDA 510(k), K153689, STERIZONE Sterilizer

FDA 510(k), K153689, STERIZONE Sterilizer

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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: KXA
Date Received: 12/23/2015
Decision Date: 06/30/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital

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