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

    QUALI-MED'S OPERATING ROOM DRAPES

    K Number: K862172 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    7
    Review Days
    10

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    Basic Information

    Device Name
    QUALI-MED'S OPERATING ROOM DRAPES
    K Number
    K862172
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Quali-Med, Inc.
    Date Received
    June 9, 1986
    Decision Date
    June 19, 1986
    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 Quali-Med, Inc.

    K Number Device Name
    K871408 BLOOD VESSEL CONNECTOR
    K862972 DISPOSABLE MIRROR
    K862472 QUARTZ RODS TITANIUM RODS
    K862241 STANDARD BASIN KIT CUSTOM BASIN KIT
    K862242 PAP SMEAR KIT
    K861198 CUSTOM PROCEDURE KIT (VARIOUS SUB-TITLES)