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

    P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL

    K Number: K863950 · Decision Oct 24, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    14

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    Basic Information

    Device Name
    P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL
    K Number
    K863950
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Precision Surgical Industries, Inc.
    Date Received
    October 10, 1986
    Decision Date
    October 24, 1986
    Product Code
    GDX
    Advisory Committee
    General, Plastic Surgery
    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
    GDX Scalpel, One-Piece

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    Other Clearances by Precision Surgical Industries, Inc.

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    K863951 P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE