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510(k) Data Aggregation
K Number
K964332Device Name
EAGLE CENTURY STEAM STERILIZER
Manufacturer
AMSCO INTL., INC.
Date Cleared
1998-06-01
(579 days)
Product Code
FLE
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
AMSCO INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STERIS Eagle Century Steam Sterilizer is designed for efficient, sterilization of non-porous and porous, heat and moisture-stabile materials used in healthcare facilities.
Device Description
The AMSCO brand Eagle Century Steam Sterilizer is a Class II medical device as defined by 21 CFR §880.6880. The Eagle Century Steam Sterilizer is a sliding door sterilizer, offered in either a prevacuum or gravity configuration, intended for the terminal sterilization of heat and moisture-stabile materials.
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