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

    STERILE DISPOSABLE EQUIPMENT MAGNET COVER

    K Number: K970185 · Decision Apr 10, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    8
    Review Days
    83

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    Basic Information

    Device Name
    STERILE DISPOSABLE EQUIPMENT MAGNET COVER
    K Number
    K970185
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Contour Fabricators, Inc.
    Date Received
    January 17, 1997
    Decision Date
    April 10, 1997
    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 Contour Fabricators, Inc.

    K Number Device Name
    K090773 CFI ULTRASOUND PROBE DRAPE
    K970900 INSTRUMENT HOLDER
    K971040 CABLE HOLDER, SUCTION TUBE HOLDER
    K964141 GE STERILE DISPOSABLE EQUIPMENT COIL COVER
    K963453 CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046)
    K820692 BANDBAG, WRAP, STERILE
    K782155 GENERAL EQUIPMENT COVER