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

    LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE

    K Number: K951418 · Decision Apr 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    6
    Review Days
    17

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    Basic Information

    Device Name
    LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
    K Number
    K951418
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lorons International Corp.
    Date Received
    March 28, 1995
    Decision Date
    April 14, 1995
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

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    Other Clearances by Lorons International Corp.

    K Number Device Name
    K945960 LORREX NON-WOVEN SPONGES NON-STERILE, STERILE, DRESSINGS
    K942692 LORREX HEALTH PRODUCTS-FLUFF GAUZE ROLLS; GAUZE CONFORMING BANDAGES STERILE AND NON STERILE
    K943184 LORREX HEALTH PROD COTTON FILLED SPONGES STERILE 2'S
    K942691 LORREX POST OPERATIVE SPONGES
    K941956 LORREX GAUZE PADS