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

    HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12

    K Number: K060363 · Decision Jul 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    40
    Applicant Total
    5
    Review Days
    144

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    Basic Information

    Device Name
    HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
    K Number
    K060363
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemcon, Inc.
    Date Received
    February 13, 2006
    Decision Date
    July 7, 2006
    Product Code
    OLR
    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
    OLR Oral Wound Dressing

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    Other Clearances by Hemcon, Inc.

    K Number Device Name
    K071519 HEMCON CHITOFLEX-SURGICAL DRESSING
    K043050 HEMCON BANDAGE AND HEMCON BANDAGE OTC
    K030946 HEMCON BANDAGE OTC; HEMCON CATH/AID
    K023298 HEMCON BANDAGE