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

    PATIENT PREP KITS/TRAYS-STERILE

    K Number: K821044 · Decision Jun 23, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    6
    Review Days
    70

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    Basic Information

    Device Name
    PATIENT PREP KITS/TRAYS-STERILE
    K Number
    K821044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Phoenix Glove Co.
    Date Received
    April 14, 1982
    Decision Date
    June 23, 1982
    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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