BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    SINGH SPEECH SYSTEM (SERIES 'SSS')

    K Number: K912486 · Decision Sep 4, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    39
    Applicant Total
    43
    Review Days
    458

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    Basic Information

    Device Name
    SINGH SPEECH SYSTEM (SERIES 'SSS')
    K Number
    K912486
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3730
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Exmoor Plastics , Ltd.
    Date Received
    June 4, 1991
    Decision Date
    September 4, 1992
    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 Exmoor Plastics , Ltd.

    K Number Device Name
    K093863 EPIDRUM
    K990366 EXMOOR SUCTION CLEARANCE KIT
    K980828 EXMOOR MYRINGOTOMY KIT
    K981143 DILKES LASER/SUCTION CANNULAE
    K972700 EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
    K981088 MILLS COLUMELLA PROSTHESIS
    K981045 EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
    K974008 PFLEIDERER'S INTRATYMPANIC CATHETER
    K974224 ENDOLYMPHATIC SAC TO MASTOID T-SHUNT
    K973587 EXMOOR TYMPANOCENTESIS KIT (TK/1)
    Search all 43 clearances from Exmoor Plastics , Ltd. →