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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, steam
510(k) Number K030789
Device Name AMSCO CENTURY STEAM STERILIZER
Applicant
STERIS Corporation
2424 WEST 23RD ST.
ERIE,  PA  16506
Applicant Contact LORI HALLER
Correspondent
STERIS Corporation
2424 WEST 23RD ST.
ERIE,  PA  16506
Correspondent Contact LORI HALLER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/12/2003
Decision Date 03/26/2003
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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