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

    SECURE-WRAP (TM) STERILIZATION WRAP

    K Number: K971483 · Decision Jun 24, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    20
    Review Days
    62

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    Basic Information

    Device Name
    SECURE-WRAP (TM) STERILIZATION WRAP
    K Number
    K971483
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Threshold Industries, Inc.
    Date Received
    April 23, 1997
    Decision Date
    June 24, 1997
    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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