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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K250029
Device Name ONE TRAY® Sealed Sterilization Container System
Applicant
Innovative Sterilization Technologies
7625 Paragon Road
Dayton,  OH  45459
Applicant Contact Walter Oko
Correspondent
Aztech Regulatory & Quality LLC
543 Long Hill Avenue
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number880.6850
Classification Product Code
KCT  
Date Received01/06/2025
Decision Date 05/01/2025
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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