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

    CURAFIL WOUND GEL DRESSING

    K Number: K943073 · Decision Jul 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    144
    Applicant Total
    66
    Review Days
    28

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    Basic Information

    Device Name
    CURAFIL WOUND GEL DRESSING
    K Number
    K943073
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Kendall Healthcare Products Co. Div.Of Tyco Health
    Date Received
    June 28, 1994
    Decision Date
    July 26, 1994
    Product Code
    MGQ
    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
    MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

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    Other Clearances by Kendall Healthcare Products Co. Div.Of Tyco Health

    K Number Device Name
    K973763 KENDALL CURITY IODOFORM PACKING STRIP
    K973511 KENDALL CURITY PETROLATUM GAUZE
    K973507 KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)
    K973619 KENDALL CURITY NON-ADHERING DRESSING
    K973509 KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING
    K973546 KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
    K970266 KENDALL HYDROPHILIC POWDER WOUND DRESSING
    K963446 KENDALL DUAL LUMEN CATHETER
    K964899 KENDALL CURITY URETERAL CATHETER
    K964519 CURITY THORACENTESIS TRAY
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