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

    DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX

    K Number: K042526 · Decision Apr 25, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    8
    Review Days
    220

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    Basic Information

    Device Name
    DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
    K Number
    K042526
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Action Industries, Inc.
    Date Received
    September 17, 2004
    Decision Date
    April 25, 2005
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by Medical Action Industries, Inc.

    K Number Device Name
    K042527 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107
    K022948 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L
    K946019 SURGICLA INSTRUMENT KIT
    K923846 BURN DRESSING
    K884826 GAUZE SPONGE
    K810685 SUTURE REMOVAL KIT
    K810184 LAPAROTOMY SPONGE