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

    PuraStat-OM

    K Number: K210211 · Decision Oct 8, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    7
    Review Days
    254

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    Basic Information

    Device Name
    PuraStat-OM
    K Number
    K210211
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3-D Matrix, Inc.
    Date Received
    January 27, 2021
    Decision Date
    October 8, 2021
    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 3-D Matrix, Inc.

    K Number Device Name
    K222481 PuraStat
    K213552 PuraStat-RM
    K210098 PuraStat-GI
    K193085 PuraDERM Gel
    K183015 PuraSinus
    K143058 PuraDerm Gel