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

    AQUAPLAST

    K Number: K935067 · Decision May 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    123
    Registration Numbers
    124
    Same Product Code
    717
    Applicant Total
    8
    Review Days
    218

    Basic Information

    Device Name
    AQUAPLAST
    K Number
    K935067
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5050
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WFR/AQUAPLAST CORP.
    Date Received
    October 20, 1993
    Decision Date
    May 26, 1994
    Product Code
    IYE
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IYE Accelerator, Linear, Medical

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    Other Clearances by WFR/AQUAPLAST CORP.

    K Number Device Name
    K120916 QFIX RADIOTHERAPY CHAIR
    K060671 KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS
    K032156 ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT
    K021124 ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER
    K973370 AQUAPLAST PALATAL STENT
    K943871 AQUAPLAST TIE DOWN DRESSING
    K942158 AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS