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

    REGENECARE WOUND GEL

    K Number: K020540 · Decision Nov 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    9
    Review Days
    255

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    Basic Information

    Device Name
    REGENECARE WOUND GEL
    K Number
    K020540
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mpm Medical., Inc.
    Date Received
    February 19, 2002
    Decision Date
    November 1, 2002
    Product Code
    SEJ
    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
    SEJ Wound Dressings Containing Topical Analgesics

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    Other Clearances by Mpm Medical., Inc.

    K Number Device Name
    K060340 ORAMAGIC PLUS ORAL WOUND RINSE
    K024180 ORAMAGICRX ORAL WOUND RINSE
    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)