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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Foam Or Gel Chemical Sterilant/High Level Disinfectant
510(k) Number K242732
Device Name Tristel OPH
Applicant
Tristel Solutions , Ltd.
Unit 1b, Lynx Business Park, Fordham Rd.
Snailwell
Cambridgeshire,  GB CB8 7NY
Applicant Contact Julija Shabanova
Correspondent
Tristel Solutions , Ltd.
Unit 1b, Lynx Business Park, Fordham Rd.
Snailwell
Cambridgeshire,  GB CB8 7NY
Correspondent Contact Véronique Li
Classification Product Code
QWS  
Date Received09/10/2024
Decision Date 05/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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