FDA 510(k), K193254, 3M Attest Steam Chemical Integrator
FDA 510(k), K193254, 3M Attest Steam Chemical Integrator
Device Name: 3M Attest Steam Chemical Integrator
Manufacturer: Mary Fretland
Device Classification Name: Indicator, Physical/Chemical Sterilization Process
Regulation Number: JOJ
Classification Product Code: KXA
Date Received: 11/26/2019
Decision Date: 12/23/2019
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General Hospital
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