BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS

    K Number: K861015 · Decision Apr 22, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    27
    Review Days
    35

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    Basic Information

    Device Name
    ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS
    K Number
    K861015
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Acme United Corp.
    Date Received
    March 18, 1986
    Decision Date
    April 22, 1986
    Product Code
    FOZ
    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
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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    Other Clearances by Acme United Corp.

    K Number Device Name
    K961323 LYOFOAM EXTRA C ODOR ABSORBING WOUND DRESSING
    K961452 LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING
    K952565 LYOFOAM EXTRA
    K895764 MODIFIED LYOFOAM WOUND DRESSINGS
    K871740 LYOSHEET SURGICAL SHEET FOR BURNS
    K864084 LYOFOAM C ODOR-ABSORBING DRESSING
    K860085 LYOFOAM WOUND DRESSINGS
    K860818 ONE TIME ENTERAL FEEDING BAG
    K842186 ACU-DERM TRANSPARENT WOUND DRESSING
    K842064 ACU-DERM TRANSPARENT IV DRESSING
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