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

    ORAMAGICRX ORAL WOUND RINSE

    K Number: K024180 · Decision Mar 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    9
    Review Days
    86

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    Basic Information

    Device Name
    ORAMAGICRX ORAL WOUND RINSE
    K Number
    K024180
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mpm Medical., Inc.
    Date Received
    December 18, 2002
    Decision Date
    March 14, 2003
    Product Code
    OLR
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OLR Oral Wound Dressing

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    Other Clearances by Mpm Medical., Inc.

    K Number Device Name
    K060340 ORAMAGIC PLUS ORAL WOUND RINSE
    K020540 REGENECARE WOUND GEL
    K992074 MPM REGENECARE WOUND GEL
    K962160 MPM HYDROGEL DRESSING (NON-STERILE)
    K952276 MPM HYDROGEL DRESSING
    K942798 MPM HYDROGEL
    K930560 MPM HYDROGEL SATURATED DRESSING
    K926044 MPM WET DRESSING (SALINE)