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

    PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-

    K Number: K843469 · Decision Nov 19, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    344
    Registration Numbers
    344
    Same Product Code
    83
    Applicant Total
    17
    Review Days
    74

    Basic Information

    Device Name
    PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
    K Number
    K843469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    ZIMMAR CONSULTING LTD.
    Date Received
    September 6, 1984
    Decision Date
    November 19, 1984
    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

    STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP

    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 ZIMMAR CONSULTING LTD.

    K Number Device Name
    K860322 CLINISET INFUSION SET
    K843478 PHARMA-PLAST URIDROP-URIDOME
    K843477 PHARMA-PLAST RECTAL TIP
    K843468 PHARMA-PLAST SUCTION SET TYPE YANKAUER
    K843467 PHARMA-PLAST NASAL OXYGEN CANNULA
    K843466 PHARMA-PLAST OXYGEN CATHETER
    K843470 PHARMA-PLAST CONNECTING TUBE TYPE SUCT-
    K843472 PHARMA-PLAST SYRINGE WITH NEEDLE
    K843471 PHARMA-PLAST SYRINGE
    K843473 PHARMA-PLAST INSULIN SYRINGE
    Search all 17 clearances from ZIMMAR CONSULTING LTD. →