FDA 510(k) Application Details - K140494

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

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510(K) Number K140494
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant STERIS Corporation
5960 Heisley Road
Mentor, OH 44060 US
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Contact TONY PIOTRKOWSKI
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 02/27/2014
Decision Date 07/25/2014
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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