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

    GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)

    K Number: K971920 · Decision Dec 4, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    36
    Review Days
    195

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    Basic Information

    Device Name
    GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
    K Number
    K971920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Customed, Inc.
    Date Received
    May 23, 1997
    Decision Date
    December 4, 1997
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Customed, Inc.

    K Number Device Name
    K974647 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
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    K962652 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
    K962596 CUSTOMED BLOOD EXTRACTION KIT
    K961442 UNIVERSAL DRAINAGE TRAY
    K953678 STERIMED STERIZATION WRAPPER (NON-STERILE)
    K950295 WOUND CLOSURE/LACERATION TRAY
    K942177 FOLEY CATHETERIZATION TRAY
    K925018 IV PREP KIT W/O DRESSING (NON-STERILE)
    K925017 IV PREP KIT (NON-STERILE)
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