BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS

    K Number: K925185 · Decision Feb 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    8
    Review Days
    477

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    Basic Information

    Device Name
    ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
    K Number
    K925185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Louis M. Gerson Co., Inc.
    Date Received
    October 14, 1992
    Decision Date
    February 3, 1994
    Product Code
    FXX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXX Mask, Surgical

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    Other Clearances by Louis M. Gerson Co., Inc.

    K Number Device Name
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    K931288 ISOLAIR 2 FULL FACE SPLASH GUARD
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    K881910 LABELING CHANGE TO SURGICAL FACE MASK
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