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

    H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET

    K Number: K913287 · Decision Dec 18, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    73
    Applicant Total
    16
    Review Days
    147

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    Basic Information

    Device Name
    H/A PARTIAL - REGULAR & H/A PARTIAL - OFFSET
    K Number
    K913287
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3450
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    River Medical, Inc.
    Date Received
    July 24, 1991
    Decision Date
    December 18, 1991
    Product Code
    ETB
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETB Prosthesis, Partial Ossicular Replacement

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    FDA Class 2 ·Ear, Nose, Throat

    mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)

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    Other Clearances by River Medical, Inc.

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    K945298 SMARTFLOW I ADMINISTRATION SET
    K943692 SMART DOSE(TM)
    K932895 RIVER PUMP
    K933335 RIVER VIAL ADAPTER
    K915120 TEF/PLATINUM PISTON
    K915121 TEF/WIRE PISTON
    K913285 PTFE PISTON
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