FDA 510(k) Application Details - K112671

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

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510(K) Number K112671
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant AESCULAP, LTD.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact DENISE ADAMS
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 09/14/2011
Decision Date 05/04/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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