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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 K173259
Device Name Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories
Applicant
Case Medical, Inc.
19 Empire Blvd.
South Hackensack,  NJ  07606
Applicant Contact Tania Lupu
Correspondent
Case Medical, Inc.
19 Empire Blvd.
South Hackensack,  NJ  07606
Correspondent Contact Tania Lupu
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/10/2017
Decision Date 06/13/2018
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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