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

    GOWN, ISOLATION, SURGICAL (FYC)

    K Number: K882281 · Decision Jun 23, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    11
    Review Days
    23

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    Basic Information

    Device Name
    GOWN, ISOLATION, SURGICAL (FYC)
    K Number
    K882281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    A Plus International, Inc.
    Date Received
    May 31, 1988
    Decision Date
    June 23, 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 A Plus International, Inc.

    K Number Device Name
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    K093169 SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
    K031353 SOLUTION FACE MASKS
    K882283 BOUFFANT CAP
    K882284 SURGEONS CAP
    K882282 SUIT, SURGICAL
    K882280 COVER, SHOE OPERATING ROOM
    K881396 OPERATING ROOM TOWELS -STERILE & NON-STERILE
    K881395 GAUZE AND LAP SPONGES -STERILE & NON-STERILE
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