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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K222440
Device Name Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays
Applicant
Steris
5960 Heisey Rd.
Mentor,  OH  44060
Applicant Contact Anthony Piotrkowski
Correspondent
Steris
5960 Heisey Rd.
Mentor,  OH  44060
Correspondent Contact Anthony Piotrkowski
Regulation Number880.6850
Classification Product Code
FRG  
Subsequent Product Code
KCT  
Date Received08/12/2022
Decision Date 09/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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