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 6: Decision Letter Issued:

    The ODE will issue the decision letter to the submitter upon receipt of the completed 510(k) documentation from the reviewing division and clearance from the Office of Compliance. The DMC staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging into the computer. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed.

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