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510(k) Data Aggregation

    K Number
    K972383
    Device Name
    EASY-JET DEVICE
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-11-23

    (880 days)

    Product Code
    KLZ, DAT
    Regulation Number
    874.3850
    Why did this record match?
    Applicant Name (Manufacturer) :

    A. STEIN - REGULATORY AFFAIRS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.
    Device Description
    automatic injection device with a cooling mechanism
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    K Number
    K973592
    Device Name
    WALKCARE P200 SYSTEM
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-05-20

    (605 days)

    Product Code
    JOW, DAT
    Regulation Number
    870.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    A. STEIN - REGULATORY AFFAIRS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Walkcare P200 system is indicated for improved blood circulation, prevention of deep vein thrombosis and reduces pain, chronic and acute edema, leg ulcers, compartmental pressure, venous stasis and complications of poor circulation, in the lower extremeties.
    Device Description
    WalkCare P200 - A foot compression system
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    K Number
    K982754
    Device Name
    EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-01-08

    (155 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    A. STEIN - REGULATORY AFFAIRS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EC 1000-7 Digital Endoscopy Video Camera is a device used for monitoring and recording during endoscopic procedures.
    Device Description
    EC 1000-7 Digital Endoscopy Video Camera (Models EC 1000-7P (PAL) & EC 1000-7 (NTSC))
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    K Number
    K973590
    Device Name
    HEMORRELIEF DEVICE
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1998-02-05

    (136 days)

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

    A. STEIN - REGULATORY AFFAIRS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemorrelief device is intended to provide treatment for the relief of pain, itching, inflammation and bleeding of hemorrhoids by means of cryotherapy (controlled cold treatment).
    Device Description
    Not Found
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    K Number
    K973148
    Device Name
    MACOM
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1997-11-20

    (90 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    A. STEIN - REGULATORY AFFAIRS CONSULTING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MACOM ™ performs real-time digital image enhancement of screen/film mammograms.
    Device Description
    MACOM™ Image Processing System
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