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FDA 510(k) Application Details - K142529
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K142529
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
CareFusion 2200 Inc
75 N Fairway Drive
Vernon Hills, IL 60061 US
Other 510(k) Applications for this Company
Contact
Jane Weber
Other 510(k) Applications for this Contact
Regulation Number
880.6850
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Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/2014
Decision Date
01/08/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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