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

    NON-STERILE GAUZE SPONGE

    K Number: K891054 · Decision May 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    148
    Registration Numbers
    148
    Same Product Code
    9
    Applicant Total
    7
    Review Days
    63

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    Basic Information

    Device Name
    NON-STERILE GAUZE SPONGE
    K Number
    K891054
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    872.6050
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Dispomed, Inc.
    Date Received
    February 27, 1989
    Decision Date
    May 1, 1989
    Product Code
    KHR
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KHR Absorber, Saliva, Paper

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    Other Clearances by Dispomed, Inc.

    K Number Device Name
    K892748 PATIENT EXAM GLOVES (MFG. AMMATEX)
    K891051 SURGICAL FACE MASK-EAR LOOP
    K891058 DENTAL GOWN
    K891052 SPLASH GUARD GOGGLE
    K891053 DENTAL BIB
    K891056 SURGICAL CONE MASK