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

    GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR

    K Number: K952569 · Decision Jan 5, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    10
    Applicant Total
    9
    Review Days
    214

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    Basic Information

    Device Name
    GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
    K Number
    K952569
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4100
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gamp & Assoc.
    Date Received
    June 5, 1995
    Decision Date
    January 5, 1996
    Product Code
    HQR
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HQR Apparatus, Cautery, Radiofrequency, Ac-Powered

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    Other Clearances by Gamp & Assoc.

    K Number Device Name
    K952581 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC VISCOINJECTOR
    K952585 GAMP & ASSOCIATES DISPOSABLE END IRRIGATING ENDOILLUMINATOR
    K954306 GAMP & ASSOC. DISPOSABLE ILL ENDOCULAR LASER PROBE
    K954308 GAMP & ASSOC. DISPOSABLE ASPIRATING ENDOOCULAR LASER PROBE
    K954307 GAMP & ASSOC. DISPOSABLE ENDOOCULAR LASER PROBE
    K952584 GAMP & ASSOCIATES DISPOSABLE ENDOILLUMINATOR W/PICK
    K952580 GAMP & ASSOCIATES DISPOSABLE BARE END FIBER
    K952586 GAMP & ASSOCIATES DISPOSABLE FIBEROPTIC ENDOILLUMINATOR