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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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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.
Click here to learn more...
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