BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DALE I.V. IDENTIFIER; PRODUCT #1125

    K Number: K894586 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    63
    Applicant Total
    13
    Review Days
    22

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    Basic Information

    Device Name
    DALE I.V. IDENTIFIER; PRODUCT #1125
    K Number
    K894586
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.5210
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Dale Medical Products, Inc.
    Date Received
    July 24, 1989
    Decision Date
    August 15, 1989
    Product Code
    KMK
    Advisory Committee
    General Hospital
    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
    KMK Device, Intravascular Catheter Securement

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    Other Clearances by Dale Medical Products, Inc.

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    K914245 DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
    K905231 DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT.
    K873311 DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
    K864897 DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335
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