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

    BLOM-SINGER LOW PRESSURE VOICE PROSTHES

    K Number: K842896 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    31
    Review Days
    25

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    Basic Information

    Device Name
    BLOM-SINGER LOW PRESSURE VOICE PROSTHES
    K Number
    K842896
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    American V. Mueller
    Date Received
    July 23, 1984
    Decision Date
    August 17, 1984
    Product Code
    EWL
    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
    EWL Prosthesis, Laryngeal (Taub)

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    Other Clearances by American V. Mueller

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    K871685 HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
    K864676 HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
    K862772 V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
    K861471 V. MUELLER VITAL CLIP-HEMOSTATIC CLIP
    K854568 V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP
    K854049 HEYER-SCHULTE SYRINGO PERITONEAL SHUNT
    K851082 V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
    K851974 V. MUELLER VITAL SKIN STAPLER
    Search all 31 clearances from American V. Mueller →