Wellkang® LLC
  • Introduction

  • List of Official Steps:
    1. Log-in Procedures
    2. Division Acceptance Criteria
    3. Reviewer Assignment
    4. FDA Requests for
      Additional Information

    5. Administrative Review
    6. Decision Letter Issued
  • 510(k) Status Program

    February 11, 2002:

    The FDA requires that all non-US medical device manufacturers wishing to market their products in the United States must have a local representative in the US, i.e. the “US Agent”.

    Wellkang LLC is your reliable “US Agent” in dealing with FDA.



      Step 2: Division Acceptance Criteria (Part a)

    After the 510(k) is logged in by the DMC, one copy is maintained there and the other is sent to the division appropriate for the classification of the device within ODE. The ODE divisions are as follows:
    • Division of General, Restorative and Neurological Devices
    • Division of Dental, Infection Control, and General Hospital Devices
    • Division of Clinical Laboratory Devices
    • Division of Cardiovascular and Respiratory Devices
    • Division of Ophthalmic and Ear, Nose, and Throat Devices
    • Division of Reproductive, Abdominal, and Radiological Devices
    A designated person within the division will review the submission against the "Refuse to Accept" checklist. A recommendation to accept the 510(k) or issue a "Refuse to Accept" letter will be forwarded to the division supervisor for concurrence.    Click here to continue...

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