BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SSW-STERILE SOLUTION WARMER

    K Number: K002859 · Decision Nov 16, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    64

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    Basic Information

    Device Name
    SSW-STERILE SOLUTION WARMER
    K Number
    K002859
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5950
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kmi Kolster Methods, Inc.
    Date Received
    September 13, 2000
    Decision Date
    November 16, 2000
    Product Code
    LHC
    Advisory Committee
    Physical Medicine
    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
    LHC Warmer, Irrigation Solution

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    Other Clearances by Kmi Kolster Methods, Inc.

    K Number Device Name
    K060414 KOLSTER METHODS, INC., FEATHERLIFT SILHOUETTE SUTURE
    K043591 FEATHERLIFT EXTENDED APTOS THREAD
    K012236 STARS2000 POWER CANNULA
    K010702 XUB EXTERNAL ULTRASOUND
    K991203 IRRIGATION OR INFUSION PUMP K PUMP