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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 K252854
Device Name SteriTite Container System with MediTray Products
Applicant
Case Medical, Inc.
50 W. St.
Bloomfield,  NJ  07003
Applicant Contact Marcia Frieze
Correspondent
Case Medical, Inc.
50 W. St.
Bloomfield,  NJ  07003
Correspondent Contact Marcia Frieze
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/08/2025
Decision Date 06/03/2026
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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