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

    AIR MAX EXTERNAL NASAL DILATOR STRIP

    K Number: K962400 · Decision Sep 9, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    115
    Same Product Code
    19
    Applicant Total
    10
    Review Days
    80

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    Basic Information

    Device Name
    AIR MAX EXTERNAL NASAL DILATOR STRIP
    K Number
    K962400
    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
    American White Cross, Inc.
    Date Received
    June 21, 1996
    Decision Date
    September 9, 1996
    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 American White Cross, Inc.

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    K854809 WHITE CROSS STERILE PAD 4IN. X 4IN.
    K853558 DOSIMETRIC RELEASE/RADIATION STERILIZ. ABSORB GAUZ
    K853334 NON-ADHERA ADHESIVE PAD 3X4
    K852408 EXTRA LARGE ADHESIVE STRIPS
    K852412 NON-ADHERENT PAD
    K852462 TRICOT ADHESIVE BANDAGE
    K850595 3 X 4 NON-ADHERENT PAD