FDA 510(k) Application Details - K142529

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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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
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Contact Jane Weber
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Regulation Number 880.6850

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Classification Product Code KCT
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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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