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

    DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE

    K Number: K051487 · Decision Dec 22, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    32
    Applicant Total
    13
    Review Days
    199

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    Basic Information

    Device Name
    DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
    K Number
    K051487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Doctor'S Research Group, Inc.
    Date Received
    June 6, 2005
    Decision Date
    December 22, 2005
    Product Code
    KHJ
    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
    KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)

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    ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

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    Other Clearances by Doctor'S Research Group, Inc.

    K Number Device Name
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    K011736 DRG QUICKMIX
    K013786 DRG ORTHOHEX SS BONE SCREW
    K002047 DRG PURETONE STETHOSCOPE WITH DRG ANTIMICROBIAL, STETHOSCOPE DIAPHRAGM, MODEL PT2B27(CARDIOLOGY), PT3B27(CLASSIC), PT5B2
    K991714 DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
    K990212 LOCKJAW 15 MINUTE INTERMAXILLARY FIXATION SYSTEM,MODEL LJ100-00
    K990920 DRG TITANIUM BONE PLATE
    K981881 DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
    Search all 13 clearances from Doctor'S Research Group, Inc. →