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

    DEY VIAL SODIUM CHLORIDE 3%

    K Number: K972778 · Decision Oct 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    507
    Applicant Total
    6
    Review Days
    75

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    Basic Information

    Device Name
    DEY VIAL SODIUM CHLORIDE 3%
    K Number
    K972778
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5630
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dey Laboratories, Inc.
    Date Received
    July 25, 1997
    Decision Date
    October 8, 1997
    Product Code
    CAF
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CAF Nebulizer (Direct Patient Interface)

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    Other Clearances by Dey Laboratories, Inc.

    K Number Device Name
    K910239 NEBU-SOL METERED DOSE DISPENSER (TM)
    K880411 DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE
    K875024 DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP
    K875011 DEY-PAK PURIFIED WATER, USP, STERILE
    K831532 OCULAR IRRIGATING CANNULA