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

    POST SURGICAL KIT/POST BIOPSY KIT

    K Number: K910011 · Decision Mar 27, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    84

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    Basic Information

    Device Name
    POST SURGICAL KIT/POST BIOPSY KIT
    K Number
    K910011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5075
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Dermatological Research Laboratories, Inc.
    Date Received
    January 2, 1991
    Decision Date
    March 27, 1991
    Product Code
    MCY
    Advisory Committee
    General Hospital
    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
    MCY Wound Dressing Kit

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