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510(k) Data Aggregation

    K Number
    K961097
    Device Name
    ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES
    Manufacturer
    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
    Date Cleared
    1996-06-03

    (76 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
    Device Description
    The DeRoyal Surgical Electrosurgical Grounding Pad Adapter functions in the same manner as predicate devices in that it sed to connect one type of electrosurgical grounding pad to a particular type of jack on the electrosurgical cautery ... achine being used. Device Design/Materials Used/Physical Properties: The DeRoyal Grounding Pad Adapter is made of materials commonly used for their purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.
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    K Number
    K961085
    Device Name
    DEROYAL WOUND CARE MULTIDEX PLUS GEL WOUND DRESSING
    Manufacturer
    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
    Date Cleared
    1996-05-21

    (63 days)

    Product Code
    MGQ
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Industries. Inc. Multider "Plus Oel in chronic, non-healing wounds, ulcers, and over burns to provide a procecive film and a moist wound environment conducive to healing.
    Device Description
    The DeRoy I Industrics, In Multidex "Plus Gel is the same as Multidex" Plus Powder in the same manner as Multider " Plus Powder, it is used in case of thoric, nombaling would, ut car, and over burn as a protection in the same in the same prodicate devices, the plater, in the strong nonealing would , ulces, ac over buns as a pocecive film. Like that for the devices is used o cover wouds and a provide a moist the basis for the device is a bot the proces and in provide a most environment conductive on healing concept of the bacesing be the form the basis for the decise in that the Device DesignMaterials UsedPhysical Propries: The proposed DeRoyal Industries, Inc. Multics I Plus Gr. Includes the same materials as the same of the country stour riop. The proposed Dekoyal Industries, Inc. Multies." Plus Colincludes the same Multidex Plus Powder. The concept of use is that it can be easi
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    K Number
    K961087
    Device Name
    DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS
    Manufacturer
    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
    Date Cleared
    1996-05-16

    (58 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.
    Device Description
    The DeRoyal Surgical Electrosurgical Cautery Pencil Adapter functions in the same manner as predicate devices in that it is used to connect one type of electrosurgical Cautery Pencil to a particular type of jack on the electrosurgical cautery machine being used. Device Design/Materials Used/Physical Properties: The DeRoyal Cautery Pencil Adapter is made of materials commonly used for its purpose. The concept of use is that the adapter converts one type of connection to another type of connection without any alteration of the circuit or any impact on the original circuit.
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    K Number
    K954716
    Device Name
    DEROYAL INDUSTRIES INFANT HEEL WARMER
    Manufacturer
    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES
    Date Cleared
    1996-01-11

    (90 days)

    Product Code
    MPO
    Regulation Number
    890.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    DEBUSK KNITTING MILLS, DIV. DEROYAL INDUSTRIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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