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

    MEGA PARACENTESIS KIT

    K Number: K913382 · Decision Oct 8, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    71

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    Basic Information

    Device Name
    MEGA PARACENTESIS KIT
    K Number
    K913382
    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
    Mega Medical, Inc.
    Date Received
    July 29, 1991
    Decision Date
    October 8, 1991
    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 Mega Medical, Inc.

    K Number Device Name
    K915863 MEGA AMNIOCENTESIS KIT
    K913317 MEGA ARTHROGRAM KIT
    K913397 MEGA ANGIOGRAM KIT
    K912445 MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
    K912322 MEGA SPINAL ANESTHESIA KIT
    K912564 MEGA PERICARDIOCENTESIS KIT