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

    LORREX GAUZE PADS

    K Number: K941956 · Decision May 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    6
    Review Days
    27

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    Basic Information

    Device Name
    LORREX GAUZE PADS
    K Number
    K941956
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lorons International Corp.
    Date Received
    April 22, 1994
    Decision Date
    May 19, 1994
    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

    Similar 510(k) Clearances

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

    NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE

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    SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S

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    FDA Unclassified ·Unknown

    VITOP DRESSING

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    FDA Unclassified ·Unknown

    GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE

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    FDA Unclassified ·Unknown

    CROSSTEX NON-WOVEN SPONGES

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    FDA Unclassified ·Unknown

    GAUZE, SPONGES, CAT # 11-003

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Lorons International Corp.

    K Number Device Name
    K951418 LORREX GAUZE PADS (1'S) AND LORREX GAUZE SPONGES - STERILE 2'S AND STERILE 10'S AND NON-STERILE
    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