BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Promisemed Sharps container

    K Number: K211890 · Decision Nov 17, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    35
    Review Days
    149

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    Basic Information

    Device Name
    Promisemed Sharps container
    K Number
    K211890
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promisemed Hangzhou Meditech Co., Ltd.
    Date Received
    June 21, 2021
    Decision Date
    November 17, 2021
    Product Code
    MMK
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MMK Container, Sharps

    Similar 510(k) Clearances

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    Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong

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