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

    SPLASH GUARD GOGGLE

    K Number: K891052 · Decision Apr 12, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    606
    Applicant Total
    7
    Review Days
    44

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    Basic Information

    Device Name
    SPLASH GUARD GOGGLE
    K Number
    K891052
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Dispomed, Inc.
    Date Received
    February 27, 1989
    Decision Date
    April 12, 1989
    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 Dispomed, Inc.

    K Number Device Name
    K892748 PATIENT EXAM GLOVES (MFG. AMMATEX)
    K891054 NON-STERILE GAUZE SPONGE
    K891051 SURGICAL FACE MASK-EAR LOOP
    K891058 DENTAL GOWN
    K891053 DENTAL BIB
    K891056 SURGICAL CONE MASK