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510(k) DEN220041

Tristel Duo ULT by Tristel Solutions Limited — Product Code QWS

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
June 2, 2023
Date Received
June 29, 2022
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Foam Or Gel Chemical Sterilant/High Level Disinfectant
Device Class
Class II
Regulation Number
880.6886
Review Panel
HO
Submission Type

A foam or gel chemical sterilant/high level disinfectant is a germicide in the form of a foam or gel that is intended for use as the terminal step in high level disinfection of medical devices prior to patient use.

Other clearances for product code QWS

  • K242732 — Tristel OPH (May 9, 2025)