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

    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

    K Number: K994321 · Decision Oct 25, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    331
    Registration Numbers
    331
    Same Product Code
    83
    Applicant Total
    21
    Review Days
    308

    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
    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
    K Number
    K994321
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Automatic Liquid Packaging, Inc.
    Date Received
    December 22, 1999
    Decision Date
    October 25, 2000
    Product Code
    JOL
    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
    JOL Catheter And Tip, Suction

    Similar 510(k) Clearances

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

    STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    WELCON STERILE WATER FOR DEVICE IRRIGATION; WELCON STERILE 0.9% NORMAL SALINE FOR DEVICE IRRIGATION

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROX SALINE SOLUTION 0.9% SODIUM CHLORIDE 4 OZ. CUP 120 ML 100 ML BOTTLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HYDROX STERILE WATER 4 OZ. CUP 120 ML., HYDROX STERILE WATER 100 ML BOTTLE

    FDA 510(k)
    FDA Class 2 ·General Hospital
    View all

    Other Clearances by Automatic Liquid Packaging, Inc.

    K Number Device Name
    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
    K901301 STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
    Search all 21 clearances from Automatic Liquid Packaging, Inc. →