BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    JAIN QUICK COUNT

    K Number: K911076 · Decision May 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    92
    Same Product Code
    112
    Applicant Total
    5
    Review Days
    80

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    Basic Information

    Device Name
    JAIN QUICK COUNT
    K Number
    K911076
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5570
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Jain Surgical Equipment, Inc.
    Date Received
    March 11, 1991
    Decision Date
    May 30, 1991
    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

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    Other Clearances by Jain Surgical Equipment, Inc.

    K Number Device Name
    K913896 JAIN BLOOD SHIELD
    K911077 JAIN SUTURE PACKAGE COUNTER
    K905105 JAIN SUTURE/VESIBAND ORGANIZER
    K904536 JAIN GRAFT ASSIST