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

    MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL

    K Number: K883566 · Decision Sep 1, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    4
    Review Days
    375

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    Basic Information

    Device Name
    MEDICATED COVERING COATED W/.5% HYDRO ADHESIVE GEL
    K Number
    K883566
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Minnetonka, Inc.
    Date Received
    August 22, 1988
    Decision Date
    September 1, 1989
    Product Code
    SEK
    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
    SEK Wound Dressings With Hydrocortisone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (SEK), ordered by most recent decision date.

    MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Minnetonka, Inc.

    K Number Device Name
    K883619 MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
    K860843 CHECK-UP PLAQUE FIGHTING GUM
    K831488 DAVRON PROF. SCRUB BRUSH-DRY/STERILE