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

    ACCUPAC CUSTOM PACK KERLIX SQUARES

    K Number: K861308 · Decision May 2, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    270
    Applicant Total
    13
    Review Days
    24

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    Basic Information

    Device Name
    ACCUPAC CUSTOM PACK KERLIX SQUARES
    K Number
    K861308
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Geneva Laboratories, Inc.
    Date Received
    April 8, 1986
    Decision Date
    May 2, 1986
    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

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    Other Clearances by Geneva Laboratories, Inc.

    K Number Device Name
    K881217 GENT-L-KARE STERILE URINARY LEG BAG
    K881213 GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
    K881218 GENT-L-KARE CLEANSING ENEMA SET
    K881216 GENT-L-KARE VAGINAL IRRIGATION SET
    K861219 ACCUPAC CUSTOM SKIN SCRUB KIT
    K853265 ACCUPAC CUSTOM OPERATING ROOM PROCEDURE-DK876543
    K843206 COOK COUNTY HOSPITAL DRESSING CHANGE SET
    K844255 GENT-L-KARE STERILE I.V. START KIT
    K843090 UNIVERSITY OF CHICAGO VASCULAR ANGIOGRAM
    K830725 GENT-L-SPEC DISPOS. VAGINAL SPECULUM
    Search all 13 clearances from Geneva Laboratories, Inc. →