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

    AIRFRAME SURGICAL DRAPE SUPPORT

    K Number: K942699 · Decision Jul 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    151
    Registration Numbers
    151
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    AIRFRAME SURGICAL DRAPE SUPPORT
    K Number
    K942699
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alpha Surgical, Inc.
    Date Received
    June 8, 1994
    Decision Date
    July 13, 1994
    Product Code
    BWN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BWN Table And Attachments, Operating-Room

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    Other Clearances by Alpha Surgical, Inc.

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