The establishment registration does not really have any relationship with the 510(k) process, if you sell a medical device in the United States there are various registration requirements depending on the role of the organisation. Regarding medical device listing, the intent of the registration is the company keeps this information up to date. I am not sure there is any strong rule of what 510(k) number should be in the listing (if required), but from a practical view it should be whatever is current. This applies to any information contained in the Medical Device Listing, such as brand names or product family naming; these should be updated if changes occur.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 26-May-2021 12:58
From: Anonymous Member
Subject: Special 510(k) Establishment Registration & Listing
This message was posted by a user wishing to remain anonymous
Do the same standards apply for Establishment Registration & Listing of a device modification after Special 510(k) clearance?
If so, does the Special 510(k) number "replace" the original K number on the registration?