BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    NURSES BOUFFANT CAP

    K Number: K965237 · Decision Aug 27, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    239

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NURSES BOUFFANT CAP
    K Number
    K965237
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Copioumed Intl., Inc.
    Date Received
    December 31, 1996
    Decision Date
    August 27, 1997
    Product Code
    LYU
    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
    LYU Accessory, Surgical Apparel

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LYU), ordered by most recent decision date.

    STRYKER T4 HYTREL (R) TOGAS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FAR-EAST BOUFFANT CAPS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DISPOSABLE APRON

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DEPUY DISPOSABLE FILTER/HOOD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    AMMI MAGNI-GUARD

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SLOAN STA-DRI PANT PROTECTOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Copioumed Intl., Inc.

    K Number Device Name
    K030927 POWDERED VINYL EXAM GLOVES, WHITE
    K021961 POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: WHITE
    K021743 (MULTIPLE LABELS) POWDER-FREE POLY-VINYL EXAM GLOVES, COLOR: YELLOW
    K972624 POLY (VINYL) EXAM GLOVE, POWDER-FREE
    K971316 POLY (VINYL) EXAM GLOVE, POWDERED
    K960999 ISOLATION GOWN
    K961342 SHOE COVER, NON-STERILE