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

    DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART

    K Number: K934188 · Decision Mar 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    76
    Registration Numbers
    76
    Same Product Code
    41
    Applicant Total
    91
    Review Days
    214

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    Basic Information

    Device Name
    DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
    K Number
    K934188
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Deroyal Industries, Inc.
    Date Received
    August 26, 1993
    Decision Date
    March 28, 1994
    Product Code
    GAG
    Advisory Committee
    General Hospital
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAG Stapler, Surgical

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