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

    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012

    K Number: K974892 · Decision Oct 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    79
    Applicant Total
    6
    Review Days
    287

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    Basic Information

    Device Name
    ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
    K Number
    K974892
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acutek Adhesive Specialties, Inc.
    Date Received
    December 30, 1997
    Decision Date
    October 13, 1998
    Product Code
    MGP
    Advisory Committee
    Unknown
    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
    MGP Dressing, Wound And Burn, Occlusive

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    Other Clearances by Acutek Adhesive Specialties, Inc.

    K Number Device Name
    K974891 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
    K974890 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
    K962698 ACUTEK'S CLEARPASAGE
    K951644 ACUTEK'S CLEARPASSAGE
    K943111 TRANSPARENT DRESSING