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

    NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100

    K Number: K870806 · Decision Mar 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    7
    Review Days
    28

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    Basic Information

    Device Name
    NON-STERILE, EXTRA PLUS PAK CAT. #USPK 2100
    K Number
    K870806
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    United Surgical Corp.
    Date Received
    February 26, 1987
    Decision Date
    March 26, 1987
    Product Code
    HQC
    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
    HQC Unit, Phacofragmentation

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    Other Clearances by United Surgical Corp.

    K Number Device Name
    K902150 PIEZO HANDPIECE
    K870671 PHACOTRON DAY PAK
    K870194 UNITED SURGICAL CORP. DIATHERMIC PLUS
    K870195 UNITED SURGICAL CORP. CRYOPTIC PLUS
    K860014 SYSTEMS PLUS
    K830741 PARAMETRIC STERILITY RELEASE OF AUTO