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

    ACUTEK'S CLEARPASSAGE

    K Number: K951644 · Decision Jul 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    19
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    ACUTEK'S CLEARPASSAGE
    K Number
    K951644
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.3900
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acutek Adhesive Specialties, Inc.
    Date Received
    April 10, 1995
    Decision Date
    July 3, 1995
    Product Code
    LWF
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LWF Dilator, Nasal

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    Other Clearances by Acutek Adhesive Specialties, Inc.

    K Number Device Name
    K974891 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013
    K974892 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012
    K974890 ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002
    K962698 ACUTEK'S CLEARPASAGE
    K943111 TRANSPARENT DRESSING