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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 K240898
Device Name SteriTite rigid reusable sterilization container with MediTray Products
Applicant
Case Medical
50 W. St.
Bloomfield,  NJ  07003
Applicant Contact Michael Polozani
Correspondent
Case Medical
50 W. St.
Bloomfield,  NJ  07003
Correspondent Contact Marcia Frieze
Regulation Number880.6850
Classification Product Code
KCT  
Subsequent Product Code
FRG  
Date Received04/01/2024
Decision Date 07/31/2024
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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