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

    HEAD-UP SUPINE SAFETY SUPPORT CUSHION

    K Number: K821306 · Decision Jun 7, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    1
    Applicant Total
    3
    Review Days
    34

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    Basic Information

    Device Name
    HEAD-UP SUPINE SAFETY SUPPORT CUSHION
    K Number
    K821306
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4950
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Med-Life, Inc.
    Date Received
    May 4, 1982
    Decision Date
    June 7, 1982
    Product Code
    EPW
    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
    EPW Support, Head, Surgical, Ent

    Similar 510(k) Clearances

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    Other Clearances by Med-Life, Inc.

    K Number Device Name
    K844420 MED-LIFE EMERGENCY OXYGEN REGREATHER/RESUSCITATOR
    K821307 ANESTHECACHE