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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cap, Device Disinfectant
510(k) Number K251592
Device Name SteriHub™ Disinfecting Device and Protective Cover
Applicant
1World Vista Medical
17956 E Paria Canyon Dr.
Rio Verde,  AZ  85263
Applicant Contact Steven McQuillan
Correspondent
Honkanen Consultanting, Inc.
738 Saddle Wood Dr.
Eagan,  MN  55123
Correspondent Contact Laurie Lewandowski
Regulation Number880.5440
Classification Product Code
QBP  
Date Received05/23/2025
Decision Date 02/11/2026
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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