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Wellkang® LLC |
World Leading Consultancy in
FDA 510(k), UL, CCC Mark, CE Marking |
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Your One-Stop Reliable Partner in International Trade! |
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510(k) Submission Process |
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News - “US Agent” Needed |
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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.
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510(k) Status Program:
Applicants may request information on their 510(k) review status 90 days after
the initial log-in date of the 510(k). Thereafter, the applicant may request
status reports by submitting a Status Request Form to the CDRH. The CDRH will send the applicant a fax or letter
that includes:
- The ODE division or branch to which the 510(k) is assigned;
- The last action, and date of action, that ODE has taken regarding the 510(k);
- The position of the 510(k) in the reviewer's queue; and
- The average review time for the division or branch.
Click here to learn more...
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