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

    STANDARD BASIN KIT CUSTOM BASIN KIT

    K Number: K862241 · Decision Aug 1, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    7
    Review Days
    50

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    Basic Information

    Device Name
    STANDARD BASIN KIT CUSTOM BASIN KIT
    K Number
    K862241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Quali-Med, Inc.
    Date Received
    June 12, 1986
    Decision Date
    August 1, 1986
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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    Other Clearances by Quali-Med, Inc.

    K Number Device Name
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    K862242 PAP SMEAR KIT
    K862172 QUALI-MED'S OPERATING ROOM DRAPES
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