BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    MINT Product Family

    K Number: K192423 · Decision Sep 9, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    63
    Applicant Total
    4
    Review Days
    371

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    Basic Information

    Device Name
    MINT Product Family
    K Number
    K192423
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4840
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hans Biomed Corporation
    Date Received
    September 4, 2019
    Decision Date
    September 9, 2020
    Product Code
    NEW
    Advisory Committee
    General, Plastic Surgery
    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
    NEW Suture, Surgical, Absorbable, Polydioxanone

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    Other Clearances by Hans Biomed Corporation

    K Number Device Name
    K220549 MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014
    K171568 SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty
    K130191 MINT