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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 K112671
Device Name STERILCONTAINER SYSTEM
Original Applicant
AESCULAP, LTD.
3773 corporate parkway
center valley,  PA  18034
Original Contact denise adams
Regulation Number880.6850
Classification Product Code
KCT  
Date Received09/14/2011
Decision Date 05/04/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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