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510(k) Data Aggregation

    K Number
    K973532
    Device Name
    STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR
    Manufacturer
    DHD DIEMOLDING HEALTHCARE DIV.
    Date Cleared
    1998-03-19

    (182 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD DIEMOLDING HEALTHCARE DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1 - Purpose: The DHD Steath Metered Dose Intraler (MDI) Spacer (Without Integral Actuator) assists with the delivery of aerosolized medications when used in conjunction with commercially available Metered Dose Inhaler (MDI) canisters with then associated actuator elbows. In addition, for convenience, the MDI canister/elbow, may be stored inside of the Stealth when not in use (the spacer acts as the MDI canister/elbow holding chamber). 2 - Claims: 2.1 Use of the Stealth Spacer, without integral actuator, assists with the delivery of aerosolized medications from Metered Dose Inhaler (MDI) canisters. 2.2 Use of the Stealth Spacer reduces patient coordination and technique oriented problems associated with MDI drug delivery.
    Device Description
    Not Found
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    K Number
    K970596
    Device Name
    DHD EMERALD PRODUCT
    Manufacturer
    DHD DIEMOLDING HEALTHCARE DIV.
    Date Cleared
    1997-05-16

    (87 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD DIEMOLDING HEALTHCARE DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961973
    Device Name
    DHD ACE WITH MASK KIT
    Manufacturer
    DHD DIEMOLDING HEALTHCARE DIV.
    Date Cleared
    1996-08-15

    (87 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    DHD DIEMOLDING HEALTHCARE DIV.

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