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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K093493
Device Name AESCULAP STERILCONTAINER S
Applicant
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Applicant Contact KATHY RACOSKY
Correspondent
AESCULAP, INC.
3773 Corporate Parkway
Center Valley,  PA  18034
Correspondent Contact KATHY RACOSKY
Regulation Number880.6850
Classification Product Code
FRG  
Date Received11/10/2009
Decision Date 07/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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