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510(k) Data Aggregation
K Number
K954736Device Name
ACCESS (POWERCLAVE)
Manufacturer
Date Cleared
1996-08-15
(304 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
MDT BIOLOGIC CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with "Castle" brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.
Device Description
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. The difference between predicate sterilizer controls and the Access controls is that the Access controls are provided with more modern microprocessor/software. and interactive graphic touch screen operator interface. The chamber vessel and piping remain unchanged.
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K Number
K954940Device Name
MDT STERIGRIP DISPOSABLE, SOFT COVER, LIGHT HANDLE
Manufacturer
Date Cleared
1996-01-17
(79 days)
Product Code
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
MDT BIOLOGIC CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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