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

    MEDCO CUSTOM EAR PROTECTOR MOLD KIT

    K Number: K821187 · Decision May 27, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    8
    Review Days
    30

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDCO CUSTOM EAR PROTECTOR MOLD KIT
    K Number
    K821187
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Santa Barbara Medco, Inc.
    Date Received
    April 27, 1982
    Decision Date
    May 27, 1982
    Product Code
    EWD
    Advisory Committee
    Unknown
    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
    EWD Protector, Hearing (Insert)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (EWD), ordered by most recent decision date.

    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

    FDA 510(k)
    FDA Unclassified ·Unknown

    SUPER SILIPLUGS EAR PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    SILICONE PUTTY EAR PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    HEARSAVER

    FDA 510(k)
    FDA Unclassified ·Unknown

    THE VIRTUAL M-332

    FDA 510(k)
    FDA Unclassified ·Unknown

    DOC'S PROPLUGS EAR PLUGS

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Santa Barbara Medco, Inc.

    K Number Device Name
    K850492 NASAL SEPTAL BUTTON
    K842483 SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC
    K823921 PHYSICIANS CHOICE SILICONE EAR PUTTY
    K812069 BORES* DEPTH GAUGE
    K812071 RK IV SURGICAL BLADES
    K812070 BORES* ADJUSTABLE BLADE HOLDER
    K802638 OTOLOGICAL VENTILATION TUBES