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

    4 X 4 SPONGES, NON-STERILE

    K Number: K870282 · Decision Feb 24, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    16
    Review Days
    28

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    Basic Information

    Device Name
    4 X 4 SPONGES, NON-STERILE
    K Number
    K870282
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Medical Group, Inc.
    Date Received
    January 27, 1987
    Decision Date
    February 24, 1987
    Product Code
    NAB
    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
    NAB Gauze / Sponge,Nonresorbable For External Use

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