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

    CURITY PREMIUM CYSTOSCOPY TRAY

    K Number: K820850 · Decision May 12, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    63
    Review Days
    47

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    Basic Information

    Device Name
    CURITY PREMIUM CYSTOSCOPY TRAY
    K Number
    K820850
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    The Kendal Co.
    Date Received
    March 26, 1982
    Decision Date
    May 12, 1982
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    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
    KKX Drape, Surgical, Antimicrobial

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    Other Clearances by The Kendal Co.

    K Number Device Name
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    K991758 MONOJECT INSULIN SYRINGE
    K970969 KENDALL CURITY SUPRAPUBIC CATHETER TRAY, KIT, & REPLACEMENT SET
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    K942664 KENDALL MODEL 6325 SCD SEQUEL COMPRESSION SYSTEM
    K942774 POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
    K892434 KENDALL CURITY OXYGEN MASK
    K892438 KENDALL CURITY INTRAVASCULAR CUT DOWN TUBES
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