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

    COMBINE II WETPROOF PAD

    K Number: K923116 · Decision Oct 6, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    570
    Registration Numbers
    570
    Same Product Code
    87
    Applicant Total
    8
    Review Days
    103

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    Basic Information

    Device Name
    COMBINE II WETPROOF PAD
    K Number
    K923116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4014
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Hermitage Hospital Products, Inc.
    Date Received
    June 25, 1992
    Decision Date
    October 6, 1992
    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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    Other Clearances by Hermitage Hospital Products, Inc.

    K Number Device Name
    K941802 OR TOWEL
    K923115 CLINISORB
    K891324 HERMITEX SPONGE
    K863737 SPONGES STERILE TWIN PAKT AND SINGLES
    K843788 CUSTOM BURN DRESSING KIT
    K822987 DRESSING SPONGE
    K822623 LAPAROTOMY SPONGE