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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 K112535
Device Name GENESIS REUSABLE RIGID CONTAINER SYSTEM
Applicant
Carefusion 2200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Applicant Contact KATE FULLER
Correspondent
Carefusion 2200, Inc.
1500 Waukegan Rd.
Waukegan,  IL  60085
Correspondent Contact KATE FULLER
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/01/2011
Decision Date 04/27/2012
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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