BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER

    K Number: K923939 · Decision Jun 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    14
    Review Days
    316

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    Basic Information

    Device Name
    IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATER
    K Number
    K923939
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    American Healthcare Corp.
    Date Received
    August 5, 1992
    Decision Date
    June 17, 1993
    Product Code
    EYN
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EYN Tray, Irrigation, Sterile

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    IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE

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    KIT PAK IRRIGATION TRAY

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    Other Clearances by American Healthcare Corp.

    K Number Device Name
    K924192 I.V. START KIT (AHC-50-54954
    K923938 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATER
    K923940 IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINE
    K923941 IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
    K924193 TRACHEOSTOMY CARE SET W/ HYDRO PEROX(AHC-20-54685)
    K924191 TRACHEOSTOMY CARE SET WITH GLOVES AND EXTRA TOWEL
    K924195 TRACHEOSTOMY CARE SET W/FORCEPS & GAUZE TRACH DRES
    K924194 TRACHEOSTOMY CARE SET W/EXTRA TOWEL(AHC-20-54686)
    K923834 TRACHEOSTOMY CARE SET WITH GLOVES
    K905136 GAUZE SPONGES, INTERNAL AND EXTERNAL
    Search all 14 clearances from American Healthcare Corp. →