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510(k) Data Aggregation

    K Number
    K083320
    Device Name
    DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2009-03-06

    (114 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
    Device Description
    The Dukal 20-001 - Fenestrated Dukal Surgical Drape, Blue, 18" x 26", with 3" Fenestration, and 20-002 - Dukal Surgical Drape, Blue, 18" x 26" is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
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    K Number
    K070407
    Device Name
    DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2007-03-26

    (42 days)

    Product Code
    FXX, 200
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
    Device Description
    Dukal Surgical Masks are pleated 3 - ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
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    K Number
    K061864
    Device Name
    DUKAL SURGICAL FACE MASK TIE-ON, MODEL 1530; EAR LOOP, MODEL 1540; WITH SHIELD, MODEL 1560
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2006-09-15

    (74 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal medical / surgical masks are indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of microorganism, body fluid and particulate aerosol transfer.
    Device Description
    Dukal Surgical Masks are pleated 3 – ply masks. Inner and outer layers are made of either medical grade tissue or 100% spun-bond polypropylene. Middle layer is made of 100% melt blown polypropylene filter. Ear loops are made of soft latex free elastic loops. The nose piece for all Dukal Masks is a malleable aluminum wire. Masks with splash visors have an anti fog treated plastic shield attached to masks. All of the material used in the construction of the Dukal face masks are being used in currently marketed devices (see predicate information)
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    K Number
    K020726
    Device Name
    DUKAL DISPOSABLE VAGINAL SPECULUM, SMALL, MEDIUM, AND LARGE
    Manufacturer
    DUKAL CORP.
    Date Cleared
    2002-05-15

    (70 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Why did this record match?
    Applicant Name (Manufacturer) :

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Disposable Vaginal Speculum is used to expose the interior of the vagina.
    Device Description
    The Dukal Disposable Vaginal Speculum
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    K Number
    K984564
    Device Name
    ETHYL CHLORIDE DISPENSER
    Manufacturer
    DUKAL CORP.
    Date Cleared
    1999-12-02

    (344 days)

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

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A vapocoolant intended for topical application in management of myofacial pain, restricted motion, and muscle spasm, and for the control of pain associated with injections, minor surgical procedures and the temporary relief of minor sports injuries.
    Device Description
    Dispenser Containing a Vapocoolant
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    K Number
    K970455
    Device Name
    DUKAL NON ADHERENT DRESSING
    Manufacturer
    DUKAL CORP.
    Date Cleared
    1997-05-08

    (91 days)

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

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Absorbent non adherent dressing is used as a topical dressing to cover a wound or operative site while providing absorbency.
    Device Description
    Absorbent non adherent dressing
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    K Number
    K970457
    Device Name
    DUKAL ABD COMBINE PAD
    Manufacturer
    DUKAL CORP.
    Date Cleared
    1997-05-08

    (91 days)

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

    DUKAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.
    Device Description
    The Dukal Sterile, ABD Combine pad is used as a topical dressing to cover a wound or operative site while providing absorbency.
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    K Number
    K955476
    Device Name
    DUKAL TRANSPARENT WOUND DRESSING
    Manufacturer
    DUKAL CORP.
    Date Cleared
    1996-01-18

    (49 days)

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

    DUKAL CORP.

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

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