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510(k) Data Aggregation

    K Number
    K022112
    Device Name
    FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2003-04-03

    (279 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stomach (Gastric) Tube is intended for gastric decompression, gastric lavage, and administration of nutritional supplements and medication.
    Device Description
    All Silicone Stomach (Gastric) Tube (Model 2020)
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    K Number
    K021193
    Device Name
    FORTUNE SILICONE VACUUM SUCTION, MODEL #1300
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2003-02-12

    (303 days)

    Product Code
    HDB
    Regulation Number
    884.4340
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Vacuum Cup is to assist a clinician in delivery of an infant during childbirth.
    Device Description
    Not Found
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    K Number
    K021142
    Device Name
    ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2002-10-01

    (175 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To pass fluid to and from the urinary bladder after prostatectomy.
    Device Description
    Fortune Medical Instruments Corp. All Silicone 2-Way/3-Way Hematuria Catheters Models 4861, 4862, 4863, 4864 and 4865.
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    K Number
    K014002
    Device Name
    ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    2002-03-04

    (90 days)

    Product Code
    KOB
    Regulation Number
    876.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suprapubic Catheter is intended to use for drainage of the bladder through a needle puncture or stab wound over the bladder.
    Device Description
    Not Found
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    K Number
    K980917
    Device Name
    ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    1998-05-27

    (77 days)

    Product Code
    GCA, DAT
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.
    Device Description
    All Silicone T-Drainage Tube w/wo Eyes All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube
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    K Number
    K980919
    Device Name
    ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER
    Manufacturer
    FORTUNE MEDICAL INSTRUMENT CORP.
    Date Cleared
    1998-03-31

    (20 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORTUNE MEDICAL INSTRUMENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Foley Balloon Catheter and Nelation Catheter are intended for use as urinary catheters to pass fluids to and from the urinary bladder.
    Device Description
    All Silicone 2-Way Foley Balloon Catheter All Silicone 3-Way Foley Balloon Catheter All Silicone Nelation Catheter
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