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

    MEDCARE FORCEPS (THUMB, TISSUE)

    K Number: K861805 · Decision May 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    444
    Registration Numbers
    445
    Same Product Code
    103
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    MEDCARE FORCEPS (THUMB, TISSUE)
    K Number
    K861805
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medcomp Technologies, Inc.
    Date Received
    May 9, 1986
    Decision Date
    May 23, 1986
    Product Code
    GEN
    Advisory Committee
    General, Plastic Surgery
    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
    GEN Forceps, General & Plastic Surgery

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    Other Clearances by Medcomp Technologies, Inc.

    K Number Device Name
    K861804 MEDCARE SUTURE REMOVAL KIT
    K861806 MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
    K861807 MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
    K860683 MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS