BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    SURGICAL GARMENTS

    K Number: K880484 · Decision Jun 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    8
    Review Days
    144

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    Basic Information

    Device Name
    SURGICAL GARMENTS
    K Number
    K880484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Greene International Corp.
    Date Received
    February 4, 1988
    Decision Date
    June 27, 1988
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    Other Clearances by Greene International Corp.

    K Number Device Name
    K883827 MASKS, VARIOUS TYPES OF SURGICAL MASKS
    K883828 CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS
    K870617 VARIOUS TYES OF SURGICAL GARMENTS
    K843075 UTILITY SCISSORS DISPOSABLE ITEMS
    K843073 FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
    K843074 DISPOS. & SPONGE FORCEPS PEAN ARTERY
    K842719 STANDARD WHEELCHAIR