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

    PREFILLED WATER FOR IRRIGATION USP

    K Number: K880316 · Decision Feb 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    21
    Review Days
    34

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    Basic Information

    Device Name
    PREFILLED WATER FOR IRRIGATION USP
    K Number
    K880316
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    January 26, 1988
    Decision Date
    February 29, 1988
    Product Code
    BTO
    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
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Automatic Liquid Packaging, Inc.

    K Number Device Name
    K994321 STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    K000964 STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
    K980147 YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
    K973829 IRRIGATION BOTTLE
    K962079 HUMIDIFIER ADAPTER
    K955104 HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
    K920306 OPTI-MOL FILTERED PUNCTURE PIN
    K911770 OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
    K901762 PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
    K901362 ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
    Search all 21 clearances from Automatic Liquid Packaging, Inc. →