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

    PROVIDONE-IODINE PREP-PADS & TOWELETTES

    K Number: K830394 · Decision Apr 6, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    36
    Applicant Total
    5
    Review Days
    58

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    Basic Information

    Device Name
    PROVIDONE-IODINE PREP-PADS & TOWELETTES
    K Number
    K830394
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    H & P Industries, Inc.
    Date Received
    February 7, 1983
    Decision Date
    April 6, 1983
    Product Code
    GEC
    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
    GEC Brush, Scrub, Operating-Room

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    Other Clearances by H & P Industries, Inc.

    K Number Device Name
    K901217 TRIA-SONIC ULTRA SOUND TRANSMISSION GEL
    K871169 LUBRICATING JELLY
    K860961 GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
    K830393 PROVIDONE-IODINE SWABSTICKS