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

    SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)

    K Number: K093169 · Decision Nov 12, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    11
    Review Days
    36

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    Basic Information

    Device Name
    SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE)
    K Number
    K093169
    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
    A Plus International, Inc.
    Date Received
    October 7, 2009
    Decision Date
    November 12, 2009
    Product Code
    FYA
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    Y

    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 A Plus International, Inc.

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    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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