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

    OPPORTUNITY INCISION AND DRAINAGE TRAY

    K Number: K971088 · Decision Sep 16, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    8
    Review Days
    176

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    Basic Information

    Device Name
    OPPORTUNITY INCISION AND DRAINAGE TRAY
    K Number
    K971088
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Opportunity, Inc.
    Date Received
    March 24, 1997
    Decision Date
    September 16, 1997
    Product Code
    EFQ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EFQ Gauze/Sponge, Internal

    Similar 510(k) Clearances

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    GAUZE, SPONGES, CAT # 11-003

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    Other Clearances by Opportunity, Inc.

    K Number Device Name
    K971091 OPPURTUNITY TRACHEOSTOMY CARE KIT
    K971090 OPPORTUNITY DRESSING CHANGE TRAY
    K971093 OPPORTUNITY I.V. START KIT
    K971089 OPPORTUNITY, INC. LACERATION TRAY
    K971095 OPPORTUNITY SUTURE REMOVAL KIT
    K971061 OPPORTUNITY INC. BONE MARROW BIOPSY AND ASPIRATION TRAY
    K971062 OPPORTUNITY INC. GENERAL PURPOSE TRAY