BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    60CC IRRIGATING SYRINGE, PISTON TYPE,

    K Number: K791998 · Decision Oct 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    21

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    60CC IRRIGATING SYRINGE, PISTON TYPE,
    K Number
    K791998
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6960
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Waz Industries, Inc.
    Date Received
    October 5, 1979
    Decision Date
    October 26, 1979
    Product Code
    KYZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KYZ Syringe, Irrigating (Non Dental)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KYZ), ordered by most recent decision date.

    OtoSet- Ear Cleaning System

    FDA 510(k)
    FDA Class 1 ·General Hospital

    SINGLE CANNULA EXTENDED APPLICATOR

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TISSU TRANS HARVEST TUBING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TISSU-TRANS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    QS DELIVERY SYSTEM

    FDA 510(k)
    FDA Class 1 ·General Hospital

    IRRIGATION SYRINGE KIT

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all