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

    OPPORTUNITY, INC. LACERATION TRAY

    K Number: K971089 · Decision Sep 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    8
    Review Days
    176

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    Basic Information

    Device Name
    OPPORTUNITY, INC. LACERATION TRAY
    K Number
    K971089
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Opportunity, Inc.
    Date Received
    March 24, 1997
    Decision Date
    September 16, 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 Opportunity, Inc.

    K Number Device Name
    K971088 OPPORTUNITY INCISION AND DRAINAGE TRAY
    K971091 OPPURTUNITY TRACHEOSTOMY CARE KIT
    K971090 OPPORTUNITY DRESSING CHANGE TRAY
    K971093 OPPORTUNITY I.V. START KIT
    K971095 OPPORTUNITY SUTURE REMOVAL KIT
    K971061 OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
    K971062 OPPORTUNITY INC. GENERAL PURPOSE TRAY