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

    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057

    K Number: K020296 · Decision Jun 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    148

    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
    ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
    K Number
    K020296
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Apothecary Products, Inc.
    Date Received
    January 28, 2002
    Decision Date
    June 25, 2002
    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.

    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

    MODEL 322 CLINICAL AUDIOMETER

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Apothecary Products, Inc.

    K Number Device Name
    K140409 FLENTS PLASTIC EYE WASH CUP
    K111856 SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
    K041766 EZY-TRAVEL WRISTBAND
    K892242 PATIENT EXAMINATION GLOVES (LATEX)
    K833311 NITROGLYCERINE CONTAINER