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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 K040865
Device Name AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER
Applicant
Aesculap
3773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact MATTHEW M HULL
Correspondent
Aesculap
3773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact MATTHEW M HULL
Regulation Number880.6850
Classification Product Code
FRG  
Date Received04/02/2004
Decision Date 12/06/2004
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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