BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE

    K Number: K903614 · Decision Dec 14, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    183
    Applicant Total
    9
    Review Days
    127

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    Basic Information

    Device Name
    HARVARD/LTE LABORATORY STEAM STERILIZER AUTOCLAVE
    K Number
    K903614
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6880
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Harvard Apparatus, Inc.
    Date Received
    August 9, 1990
    Decision Date
    December 14, 1990
    Product Code
    FLE
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FLE Sterilizer, Steam

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    Other Clearances by Harvard Apparatus, Inc.

    K Number Device Name
    K970678 THE HARVARD LIBRARY
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    K903613 HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE)
    K813644 MODEL 2650 HIGH CAPACITY DUAL SYRINGE
    K801904 SYRINGE INFUSION PUMP #2716
    K800569 SYRINGE INFUSION PUMP #2720
    K791293 BATTERY POWERED SYRINGE INFUSION PUMP
    K780705 INFUSION PUMP-MODEL 2616