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

    ISOLAIR 2 FULL FACE SPLASH GUARD

    K Number: K931288 · Decision Jan 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    801
    Registration Numbers
    801
    Same Product Code
    55
    Applicant Total
    8
    Review Days
    315

    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
    ISOLAIR 2 FULL FACE SPLASH GUARD
    K Number
    K931288
    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
    Louis M. Gerson Co., Inc.
    Date Received
    March 12, 1993
    Decision Date
    January 21, 1994
    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

    NURSES BOUFFANT CAP

    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
    View all

    Other Clearances by Louis M. Gerson Co., Inc.

    K Number Device Name
    K061375 RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
    K050193 GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR
    K960778 ISOLAIR APR TYPE N95
    K925185 ISOLAIR 2 FLUID RESIST SURG/PROCE/CONE/EARLOOP MAS
    K922507 GERSON ISOLAIR APR PARTICULATE SURGICAL MASK
    K881910 LABELING CHANGE TO SURGICAL FACE MASK
    K802373 SURGICAL FACE MASK