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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 K153554
Device Name Genesis Low Temperature Reusable Rigid Container System
Applicant
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Jane Weber
Correspondent
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Jane Weber
Regulation Number880.6850
Classification Product Code
KCT  
Date Received12/14/2015
Decision Date 03/21/2016
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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