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 1: Log-in Procedures:

    Upon receipt in the CDRH Document Mail Center (DMC) located within ODE, 510(k) submissions are date stamped and logged into the DMC computer database where a unique control number is assigned to the document. This number is referred to as the "document control number", "510(k) number", or just "K number". The document control number begins with the letter "K" followed by 6 digits.

    The DMC database program will assign the 510(k) a due date and sequential position in the queue based on the receipt stamp date. The queue is a system of positioning 510(k)s in the order they are being reviewed or will be reviewed by the ODE reviewer. The database program will also generate an "acknowledgment letter" with the assigned 510(k) number. The acknowledgment letter will be mailed to the submitter or applicant if different from the submitter.

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