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

    STERIL-DERM TRANSPARENT WOUND DRESSING

    K Number: K892837 · Decision Aug 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    502
    Registration Numbers
    502
    Same Product Code
    106
    Applicant Total
    2
    Review Days
    105

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    Basic Information

    Device Name
    STERIL-DERM TRANSPARENT WOUND DRESSING
    K Number
    K892837
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biointerface Technologies, Inc.
    Date Received
    April 18, 1989
    Decision Date
    August 1, 1989
    Product Code
    NAD
    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
    NAD Dressing, Wound, Occlusive

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    Other Clearances by Biointerface Technologies, Inc.

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