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

    AM-100 I/A AMPAC

    K Number: K860770 · Decision Apr 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    315
    Applicant Total
    16
    Review Days
    49

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    Basic Information

    Device Name
    AM-100 I/A AMPAC
    K Number
    K860770
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4670
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Dravon Medical, Inc.
    Date Received
    March 3, 1986
    Decision Date
    April 21, 1986
    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 Dravon Medical, Inc.

    K Number Device Name
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    K812772 PERITONEAL DIALYSIS CYCLER SET (8UNIT)
    K811851 S-610 SHUNT ADAPTOR SET
    K800435 HEMOSTATIC/TUBE OCCLUDING FORCEPS
    K782057 CATHETER, RADIOPAQUE TENCKHOFF
    K782058 CATHETER, BETA-CAP-PERITONEAL
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